Systems, apparatuses and methods to encourage injection site rotation and prevent lipodystrophy from repeated injections to a body area

ABSTRACT

Systems and methods encourage users to rotate injection sites and avoid lipodystrophy. Sleeves and/or lost-tooth gear dials and/or microswitches in or on injection pens or their caps, on vials, and on other portable devices manually adjust an indicator before or after an injection to show a current or next injection site in accordance with a site rotation plan. Injected medicine packaging and related printed indicia encourage site rotation. Optical devices employing optical mouse or projection technology help locate and/or distribute injection sites within a body area. A mobile phone app tracks injections and locations to select next injection site, and can use imaging to locate a target injection site and optionally diagnose lipodystrophic conditions and record them. Tactile and print media educational tools are presented to help users palpate and identify lipos in body areas having injection sites.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. Ser. No.15/100,032, filed May 27, 2016, which is a 35 U.S.C. 371 U.S. nationalstage application based on International PCT Application No.PCT/US14/68469, filed Dec. 3, 2014, which claims priority from U.S.Provisional Application Ser. No. 61/911,850, filed Dec. 4, 2013, theentire contents of each being incorporated herein by reference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to methods and apparatuses that helppatients adhere to an injection site rotation plan to minimizelipodystrophy and related adverse effects such as reduced or erraticmedicament absorption and associated difficulties with managing a healthcondition employing the medicament as part of a care plan.

2. Description of Related Art

Patients requiring frequent skin invasive actions such as injections orinfusions of medicament into the skin can develop lipodystrophy at theinjection sites. Lipodystrophy is a degenerative disorder ofsubcutaneous tissue. One type of lipodystrophy is lipohypertrophy, whichcan present in a patient as thickening of tissue such as lumps, ordents, or red and swollen tissue that is hard when palpated, in theaffected area. The term “injection” as used herein can be, for example,injection by a needle (e.g., single dose syringe, or injection pen), orby infusion (e.g., a medicament pump with cannula for subcutaneousinsertion such as an insulin pump), or any other action by which apatient's outer skin is pierced or crossed to deliver a medicament or totake a sample (e.g., a blood or tissue sample).

Lipodystrophy can be problematic for the patient because it can affectthe rate of absorption of the medicament being administered byinjection. For example, insulin therapy relies on reproducibleabsorption of insulin from a patient's subcutaneous (SC) tissue. Somepatients with diabetes may require injections of a medicament (e.g.,insulin) several times per day. Repeated application of insulin in asmall skin area of a patient can induce lipodystrophic changes in thepatient's skin structure (e.g., in the fatty tissue in the SC space).For example, a patient can suffer from lipodystrophy in an affected bodyarea when he injects in that same body area and too close to adjacentinjection sites in that area within a time period that is too short induration to allow these injection site(s) to recover from the skininvasive action of the injection(s). Injection of insulin into a bodyarea affected by lipodystrophic changes to the skin structure (e.g., SCtissue that may be fibrous and relatively avascular) can, in turn,induce erratic insulin absorption since a lack of blood vessels in thevicinity of the injection location (i.e., insulin depot) can reduce therate of insulin absorption. For diabetic patients who administer insulinby injection or infusion techniques, less than optimal rate absorptioncan cause increased insulin requirements and/or poor metabolic control.Alternatively, a faster absorption rate may occur, which leads to poorglucose control.

Illustrative injection regimens will now be described with respect toinsulin administration to diabetic patients. It is to be understood thatthe illustrative embodiments of the invention described below areapplicable to other types of medical conditions requiring repetitiveinjections, and to other types of injection regimens using other typesof medicament. Example injection regimens are:

Conventional therapy: use fast-acting and intermediate-acting types ofinsulin, typically requiring 2-3 injections per day;

Multiple daily injections (MDI): mealtime injections of fast-actinginsulin to manage blood sugars during a meal and in the post-prandialperiod, and an injection of long-acting manage blood glucose levelsbetween meals, which can be at least 4 injections per day; and

Continuous subcutaneous insulin infusion (CSII): administer insulinthrough a temporary flexible catheter inserted into subcutaneous tissueand worn in rotating sites for 2-3 days or 4-5 days. Lipohypertrophy canoccur in body areas used for continuous insulin delivery systems (e.g.,subcutaneous indwelling catheters and insulin pump), as well asinjections using syringes or pen needles. Although patients may beinstructed to avoid placing catheters in areas of lipohypertrophy, theseareas are not necessarily recognized by patients or their caregiversand, as such, catheters are often placed where early lipohypertrophy isalready present.

Evidence suggests a correlation between lipodystrophy, and failure torotate injection sites or using small injection zones (e.g., body areas)repeatedly or injecting into the same location and/or re-using needles.Systematic site rotation can help to reduce the risk of developinglipohypertrophy. Thus, an easy-to-follow injection site rotation plan orscheme taught from the start of injection therapy is recommended.

With reference to FIG. 23A, eight body areas have been identified forinsulin administration, that is, right and left sides of the patient'sabdomen, arms, buttocks, and thighs. An important part of a care planfor a diabetic patient is education on and implementation of aninjection site rotation plan. A site rotation plan can includeinjections or catheterization with art infusion device in a single bodyarea (e.g., the abdomen) but using a pattern or grid to help distributeinjections over this area. For example, one illustrative rotation schemedivides the area surrounding a patient's umbilicus (e.g., a target bodyarea for injections), into sections (e.g., body area zones) such as the12 hours of a clock face as shown in FIG. 24, or quadrants centered withrespect to the umbilicus or halves of a body area such as the thigh asshown in FIG. 23B, to help a patient distribute injection sites withinthat body area.

The injection site rotation plan can also involve plural body areas. Forexample, other illustrative rotation schemes can include, but are notlimited to, a patient rotating shots among plural body areas in a givenday, or distributing shots within the same selected body area for aselected time period (e.g., a week) before rotating to another body areato distribute shots therein for the selected time period. One schemewith proven effectiveness involves dividing the target body area forinjection sites into quadrants or halves, depending on the size of thearea, using one quadrant or half per week, rotating within that areafrom day to day, and then moving clockwise each week to a new area¹. ¹Pledger et al. “Importance of Injection Technique in diabetes” Journalof Diabetes Nursing 16 No 4 2012 pp160-165.

Many patients, however, do not adhere to an adequate injection siterotation plan to avoid or minimize lipodystrophy and its relatedproblems. For example, even when advised to rotate injection sites,patients continue with a less than optimal routine of using too few bodyareas and injection sites for different reasons. One reason is the HumanFactor or ergonomic ease with which a patient can reach his or herdifferent body areas to self-inject. For example, a patient's abdomenand thighs may be easier to reach with her hands to self-inject than herback or arms. As stated above, lipodystrophy can occur because a patientinjects the same site day after day. It frequently occurs on both sidesof the umbilicus or in the mid-thigh areas as these are convenientplaces to inject for diabetic patients. Another reason patients maypurposefully or even unconsciously fail to practice an adequateinjection site rotation plan is fear of pain in new sites. Further, somepatients simply adhere to a less than optimal injection site rotationplan out of habit and for no particular reason other than not havingadequate reminders or encouragement to rotate injection sites beforelipodystrophy occurs. A need therefore exists for methods and/orapparatuses that encourage a patient to adhere to an injection siterotation plan such as, but not limited to, provide reminders, or helpthe patient keep record of past injection sites and select the nexttarget body area and/or injection site.

In addition, rotation schemes may not sufficiently distribute injectionsover a target body area. For example, one rotation plan may provide 2 or4 target areas (e.g., left, right thigh and/or left, right abdominalarea), but leave where in that area to inject to the discretion of thepatient, resulting in the patient most likely locating injections inonly a few concentrated locations or injection sites within the targetbody area. A need therefore also exists for methods and/or apparatusesthat help a patient distribute injection sites within a target bodyarea.

Effective injection site rotation is therefore an important component tomedicament administration. Early detection of a lipodystrophic site orsite at imminent risk for developing lipodystrophic characteristics, andrefraining from using such a site for a selected period of time, maypreserve that site for future medicament delivery. Some sites need to beavoided for a period of time or avoided altogether, depending on thedegree of damage done to the tissue. Further, injection sites need to benot only visually examined but also palpated since not all skin lesionsare visible. A need therefore exists for methods and/or apparatuses thathelp a patient track lipodystrophic sites and avoid using them as targetinjection sites for at least a selected period of time, and optionallyto help a patient discern whether a particular site on his or her bodyis developing lipodystrophic characteristics.

A variety of devices for administering insulin are available to diabeticpatients, and range from unit dose disposable syringes, to reusable peninjectors, to infusion sets. A need therefore also exists for methodsand/or apparatuses that encourage patients to adhere to an injectionsite rotation plan as well as accommodate their choice of insulindelivery mechanism.

SUMMARY OF THE INVENTION

The above and other problems are overcome, and additional advantages arerealized, by illustrative embodiments of the present invention.

In accordance with illustrative embodiments of the present invention,methods and systems are provided to help a user adhere to an injectionsite rotation plan to minimize lipodystrophy. The methods and systemsare implemented using a number of different form factors and devicessuch as improved injection pens, medicament containers such as vials,unit dose syringes and related packaging, infusion pump sets, variousportable devices, and mobile apps.

In accordance with aspects of illustrative embodiments of the presentinvention, a device for encouraging injection site rotation can beimplemented in a medication delivery device or be a separate device.

In accordance with aspects of illustrative embodiments of the presentinvention, a reminder system for varying the location of an injectionsite is provided that has a user-operable device including an indicatorhaving indicia thereon related to a plurality of injection sites.

In addition, the reminder system can have any one or more of thefollowing aspects:

-   -   the indicator comprises an indicator sleeve, which is rotatably        secured to one of an injection pen body, an injection pen cap,        and a medicament vial;    -   the indicator comprises an indicator sleeve, which is mounted to        one of an injection pen body, an injection pen cap, and a        medicament vial, and the system further comprises a window        sleeve rotatably mounted to the one of the injection pen body,        the injection pen cap, and the medicament vial to selectively        permit viewing of a single one of the indicia at a time;    -   the reminder system comprises an additional indicator having        indicia thereon related to days of the week, and a mechanism        linking the indicator sleeve and the additional indicator so        that advancing the additional indicator by seven indicia        advances the indicator sleeve by a single indicia. For example,        the additional indicator comprises a disc, or a sleeve. Further,        a complete rotation of the additional indicator advances the        indicator sleeve by a single indicia. The mechanism can        comprises a lost-tooth gearing;    -   the reminder system comprises a rotating mechanism wherein the        indicator comprises an indicator sleeve, which is movably        disposed inside an injection pen having an injector button, the        indicia being visible one at a time through a window disposed on        the injection pen, and distal displacement of the injector        button to complete the injection causes the rotating mechanism        to advance the indicator sleeve by a single indicia;    -   the rotating mechanism can comprise a primary advancing        protrusion disposed on the injection pen, and a plurality of        radial protrusions disposed on the indicator sleeve, each of the        plurality of radial protrusions corresponding to a single one of        the indicia, wherein upon distal displacement of the injector        button to complete an injection, the injector button displaces        the indicator sleeve distally, and the interaction between the        primary advancing protrusion and one of the radial protrusions        during the distal displacement of the indicator sleeve causes        rotation of the indicator sleeve;    -   the rotating mechanism can comprise a biasing member biasing the        indicator sleeve proximally relative to the injection pen, and a        secondary advancing protrusion disposed on the injection pen,        the secondary advancing protrusion being circumferentially and        axially offset from the primary advancing protrusion, wherein        upon proximal displacement of the indicator sleeve due to the        biasing member, the interaction between the secondary advancing        protrusion and one of the radial protrusions during the proximal        displacement of the indicator sleeve causes additional rotation        of the indicator sleeve.

In accordance with aspects of illustrative embodiments of the presentinvention, a package is provided that comprises a carton, and aplurality of medical injection devices contained within said carton,said carton having printed indicia representing body areas on a patient,and printed indicia directing the injection by the medical injectiondevices to an injection site within respective body areas of thepatient;

In addition, the package can have any one or more of the followingaspects:

-   -   the carton has a plurality of compartments, and where each        compartment contains a plurality of said medical injection        devices;    -   the package includes printed indicia identifying each of said        compartments as corresponding to respective body areas of the        patient;    -   said indicia for each of said compartments has a different        distinguishable color;    -   said indicia for each of said compartments has a different shape        for identifying a body area of the patient;    -   each of said medical injection devices include printed indicia        corresponding to the printed indicia for a respective        compartment in which the medical injection device is arranged;    -   said indicia for each of said medical injection devices        identifies an injection site within the body area of the        patient;    -   the package can comprise a chart for recording the sequence of        injection sites administered by the patient;    -   each of said medical injection devices include a label        containing said indicia identifying an injection site, and where        said labels are removable from the medical injection device and        can be adhered to the chart to record the injection site;    -   the package can be used with a software application stored in        non-transitory computer-readable memory that comprises        instructions to control a programmable processing device to        generate a display on a screen connected to the processing        device, the display comprising the indicia representing the body        areas, the processing device being controlled by the software        application to receive a user input selecting one of the indicia        on the display to correspond to an injection and its target        location in the body area represented by the selected indicia,        and to record in memory data relating to the injection        comprising date and time of the injection and selected indicia;    -   the processing device is one of a mobile phone and a mobile        computing device and the screen is a touchscreen, the user input        comprising a touchscreen selection of one of the indicia on the        display;    -   the processing device is controlled by the software application        to generate a historical report of injections occurring over a        selected period of time and their corresponding data comprising        date and time and corresponding body area.

In accordance with aspects of illustrative embodiments of the presentinvention, an adhesive tape injection site indicator removably appliedto a user's skin is provided that comprises at least one ply, said plyhaving a plurality of holes, said plurality of holes are arranged insaid ply to correspond to a selected injection site distributionpattern, wherein the pattern is arranged such that, when an injection ismade into respective ones of the plurality of holes, the pattern causesthe respective injections to be spaced apart in the body area of theuser that is covered by the indicator.

In addition, the adhesive tape injection site indicator can have any oneor more of the following aspects:

-   -   the pattern arranges the holes to be spaced apart a selected        distance to minimize lipohypertrophy in the body area when the        respective injections are administered within a selected period        of time;    -   the pattern arranges the holes to be at least the selected        distance of 0.3-2.0 centimeters from adjacent ones of the holes;    -   the adhesive tape injection site indicator comprises a plurality        of plies wherein corresponding holes in the plies are        substantially aligned with respect to each other, and indicia        are provided with respect to a different one of the holes on        respective plies to represent a target injection site on that        ply;    -   the adhesive tape injection site indicator comprises s plurality        of plies, wherein the holes on each of the plies do not overlap.

In accordance with aspects of illustrative embodiments of the presentinvention, an adhesive tape injection site indicator kit is providedthat comprises a plurality of indicators configured to be removablyapplied to a user's skin, and a template configured to indicate adistribution pattern for the indicators when they are affixed to a bodyarea of a patient to mark respective target injection sites.

In addition, the adhesive tape injection site indicator kit can have anyone or more of the following aspects:

-   -   the distribution pattern is configured to space the target        injection sites a selected distance from each other to minimize        lipohypertrophy in the body area when the respective injections        are administered within a selected period of time;    -   the distribution pattern arranges the indicators to be at least        the selected distance of 0.3-2.0 centimeters from adjacent ones        of the indicators;    -   the indicators are stickers that each comprise adhesive to affix        one side thereof to the patient;    -   the template is configured to have the indicators affixed to one        side thereof in the distribution pattern, and the indicators are        transferrable onto a patient's skin when the one side of the        template is placed against the patient;    -   the indicators are stickers that each comprise double-sided        adhesive to affix one side thereof to the one side of the        template and the other side thereof to the patient;    -   the indicators each comprise transferrable ink on one side        thereof and are configured to transfer a marking onto the        patient from the template to represent a target injection site.

In accordance with aspects of illustrative embodiments of the presentinvention, an optical tool for tracking injection sites on a patient'sbody is provided that comprises an optical mouse, a memory device, aprocessing device connected to the memory device and the optical mouse,the processing device being configured to determine distances traveledby the mouse when moved over a patient's body and assigning positioncoordinates for target injection locations based on optical mouseoutputs.

In addition, the optical tool can have any one or more of the followingaspects:

-   -   the injections can be in designated body areas on the patient        and each body area has a reference location, the processing        device being configured to determine distances traveled by the        optical mouse in a body area and assign position coordinates of        the optical mouse relative to the reference location at selected        points of the body area over which the optical mouse is being        moved;    -   the memory stores injection data comprising an injection regimen        indicating number of injections per day and recommended        injection rotation plan, and position coordinates and dates and        times of past injections, and the processing device is        configured to select a target injection site using the current        position coordinates of the optical mouse and the stored        injection data;    -   the processing device is configured to space the position        coordinates of the injection sites relative to adjacent sites by        a selected amount to reduce lipohypertrophy;    -   the memory stores injection data comprising body area sites that        are to be avoided as target injection sites, and the processing        device is configured to not use these body area sites when        selecting a target injection site;    -   the processing device is configured to generate an indication        when the current position coordinates are determined to be        proximal to a body area site that is to be avoided as a target        injection site;    -   the processing device is configured to generate an indication        when the current position coordinates are determined to be a        target injection site.

In accordance with aspects of illustrative embodiments of the presentinvention, an image projection device is provided that is configured tobe handheld and to project an injection site target image onto a bodyarea of a patient.

In addition, the image projection device can have any one or more of thefollowing aspects:

-   -   the image is a pattern representing a plurality of target        injection sites spaced apart relative to each other to reduce        lipohypertrophy;    -   the target injection sites in the pattern are spaced apart from        each other by a selected distance of 0.3-2.0 centimeters;    -   the image projection device is deployed in a reusable part of an        infusion pump set to facilitate selecting a location for        deploying an injection assembly associated with the infusion        pump;    -   the image projection device further comprises a memory device, a        user interface, a processing device connected to the image        projection device, the memory device and the user interface, the        memory device storing a plurality of injection site target        images, the user interface being configured to display a listing        of the plurality of injection site target images from which a        user can select a target image, and the processing device being        operable to control the image projection device to display a        selected target image;    -   the plurality of injection site target images comprises        different target images for use on different body areas of the        patient;    -   different target images are different sizes and shapes depending        on their corresponding body areas;    -   the plurality of injection site target images comprises at least        one target image that comprises different zones or sectors.

In accordance with aspects of illustrative embodiments of the presentinvention, a software application stored in non-transitory,computer-readable memory is provided that comprises instructions tocontrol a portable computing device having an image sensor, a screendisplay and a programmable processing device, the processing devicebeing controlled by the software application to receive image data fromthe image sensor when pointed at a body area of a patient and displaythe image data on the screen display and an image of injection sites.

In addition, the software application can have any one or more of thefollowing aspects:

-   -   the image sensor also captures an image of a user pointing to        the body area with finger or other pointer, further comprising        instructions to control the screen display to display the image        of the pointer with the image data of the body area;    -   a target injection site in the body area is selected and the        instructions control the processing device to generate feedback        data when at least a selected portion of the pointer coincides        with an orientation point corresponding to the target injection        site;    -   the feedback data is at least one of audible indicator that the        user has located the target injection site in the body area with        the pointer, and a visual indicator on the target injection site        on the screen display when the pointer reaches it in the body        area, and a visual indicator of a direction and/or distance for        moving the pointer to reach the target injection site;    -   the feedback data comprises an indicator of sites in the body        area that should be avoided for injections;    -   the instructions control the processing device to automatically        select the target injection site;    -   the processing device is controlled to analyze data comprising        an injection regimen comprising number of injections per day, at        least one target injection body area, a body area rotation plan        if more than one body area is used, at least one injection        pattern to distribute injections within a body area, and        injection data comprising date and time and locations of past        injections to automatically select the target injection site;    -   the portable computing device operates with another sensor that        records image data related to a skin condition in the body area;    -   the image data comprises infrared wavelengths;    -   the skin condition comprises at least lipohypertrophy,

One embodiment is a software program that runs on a smart phone,computer, IPAD, PDA or other portable electronic device with a graphicaldisplay that guides the user as to where to inject to preventlipodystrophic sites (e.g., hereinafter “lipos”) from forming. An imageof the body can be displayed showing the regions on the body to be usedfor injections and allow the user to zoom in on a region and site beingsuggested by the system for the next injection. The user can be providedwith an option to accept the site or advance to a new site. All usedsites are tracked and recorded so that the user can see which sites havebeen used the most when compared to other sites. The software program orapplication (hereinafter “app”) can also provide the user withinformation for identifying lipos that may exist and record thosepossible sites in device memory with date and time, so that injectionsat those locations may be avoided (e.g., for a selected period of time)and the user's doctor can be consulted. The app can also provideincentive to the user to purchase a particular vendor's ormanufacturer's needles in order to continue using the app by requiringthe user to scan the product's bar code or enter a particular key. Theapp can also provide the user with coupons when used for an extendedperiod of time. The app can be downloadable from the vendor's ormanufacturer's website or any app store.

In accordance with aspects of illustrative embodiments of the presentinvention, a lipohypertrophy education tool is provided comprising abase, and a synthetic material provided on the base having a firsttexture selected to simulate subcutaneous fatty tissue when palpated,wherein the synthetic material comprises at least one area having asecond texture selected to simulate a lipohypertrophy occurrence in thesubcutaneous fatty tissue.

In addition, the lipohypertrophy education tool can have any one or moreof the following aspects:

-   -   the base is dimensioned to be at least one of credit-card size,        to be disposed in or on packaging containing injection supplies,        to be disposed in a portable kit, and to be disposed on a wall        or other surface on display to users.

Illustrative embodiments and respective aspects thereof can be used withother illustrative embodiments.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more readily understood with reference tothe illustrative embodiments thereof as shown in the attached drawingfigures, in which:

FIG. 1 is a perspective view of an illustrative drug delivery pen;

FIG. 2 is an exploded view of the illustrative drug delivery pen of FIG.1;

FIG. 3 is a perspective view of an injection site rotation scheme;

FIG. 4 is a perspective view of an indicator sleeve in accordance withan illustrative embodiment of the present invention;

FIG. 5 is a perspective view of an injection pen in accordance with anillustrative embodiment of the present invention;

FIG. 6 is a perspective view of another injection pen in accordance withan illustrative embodiment of the present invention;

FIG. 7 is a perspective view of medicament vial in accordance with anillustrative embodiment of the present invention;

FIG. 8 is a top view of a lost-tooth gearing in accordance with anillustrative embodiment of the present invention;

FIG. 9 is a perspective view of a lost-tooth sleeve in accordance withan illustrative embodiment of the present invention;

FIG. 10 is an exploded, perspective view of components of a remindersystem in accordance with an illustrative embodiment of the presentinvention;

FIG. 11 is a partial, perspective, cross-sectional view of an injectionpen in accordance with an illustrative embodiment of the presentinvention;

FIG. 12 is a partial cross-sectional view of the pen of FIG. 11;

FIG. 13 is a perspective view of an injection pen cap in accordance withan illustrative embodiment of the present invention;

FIG. 14 is a perspective view of another injection pen cap in accordancewith an illustrative embodiment of the present invention;

FIG. 15 is a perspective view of a medicament vial in accordance with anembodiment of the present invention;

FIG. 16 is a perspective view of an indicator sleeve in accordance withan embodiment of the present invention;

FIG. 17 is a partial, cross-sectional, schematic view of an injectionpen in accordance with an illustrative embodiment of the presentinvention;

FIGS. 18-21 are diagrams illustrating operation of the injection pen ofFIG. 17;

FIGS. 22A and 22B are, respectively, a partial cross-sectional view anda partial front view of a pen in accordance with an embodiment of thepresent invention;

FIG. 22C depicts a pen having display on its pen cap for automaticallyindicating the next target injection site after pen is recapped inaccordance with an illustrative embodiment of the present invention;

FIG. 23A depicts illustrative target body areas for administeringinjections and FIG. 23B depicts illustrative zones in a target bodyarea;

FIG. 24 depicts illustrative sections or zones of a target body area foradministering injections;

FIGS. 25A and 25B depict a package (e.g., of injection supplies) havinginstructions in the form of printed indicia providing the instructions,guidelines and recommendations for the rotation of injections among bodyareas or the target injection sites within a body area in accordancewith illustrative embodiments of the present invention;

FIG. 26 depicts a package divided into separate compartmentscorresponding to a selected injection site or injection area inaccordance with an illustrative embodiment of the present invention;

FIGS. 27A and 27B depict printed indicia on packages and on stickersapplied to pen caps, syringes or other individual injection devices thatcan identify an injection site at an upper region, a lower region, aright side and a left side of a user's abdomen to encourage injectionsite rotation in accordance with an illustrative embodiment of thepresent invention;

FIG. 28 depicts a package having a chart printed on the package or as aremovable card and corresponding injection device indicia for recordingand tracking the injection sites accordance with an illustrativeembodiment of the present invention;

FIG. 29 depicts a user's abdomen as the designated body area dividedinto 12 injection sites representing a clock for which a chart can bedivided into a number of injection sites where each space on the chartcorresponds to the desired injection site in accordance with anillustrative embodiment of the present invention;

FIGS. 30A, 30B, 30C, 30D and 30E depict a sticker or other marker forapplication to a user's skin as guidance for where to locate a targetinjection site and identify previous injection site(s) on the user inaccordance with illustrative embodiments of the present invention;

FIG. 31 depicts an injection site locating (ISL) device in accordancewith an illustrative embodiment of the present invention;

FIG. 32 depicts an injection site projection (ISP) device in accordancewith an illustrative embodiment of the present invention;

FIG. 33 is a block diagram of a mobile phone with mobile app inaccordance with illustrative embodiments of the present invention;

FIGS. 34, 35, 37 and 38 are diagrams of respective screen displays on amobile phone with mobile app in accordance with an illustrativeembodiment of the present invention;

FIGS. 36A and 36B are a flow chart of operations of a mobile phone withmobile app in accordance with an illustrative embodiment of the presentinvention; and

FIGS. 39A, 39B, 40A, 40B, 40C, 40D, 40E, 40F, 41 and 42 arelipohypertrophy education devices constructed in accordance withillustrative embodiments of the present invention.

Throughout the drawing figures, like reference numbers will beunderstood to refer to like elements, features and structures.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Reference will now be made in detail to embodiments of the presentinvention, which are illustrated in the accompanying drawings. Theembodiments described herein exemplify, but do not limit, the presentinvention by referring to the drawings. As will be understood by oneskilled in the art, terms such as up, down, bottom, and top arerelative, and are employed to aid illustration, but are not limiting.

Illustrative embodiments of the present invention will now be describedthat encourage users (e.g., patients and/or their caregivers) topractice injection site rotation and therefore avoid or minimize theoccurrence of lipodystrophy in patients and the above-mentionedpotentially adverse effects of administering medicaments intolipodystrophic body areas of patients.

The illustrative embodiments of the present invention provide users withchoices of different tools (e.g., different media and/or devices andformats) for tracking locations of injection sites, as well as rotationof target injection sites among different body areas or at least withina zone or section of a target body area for medicament administration byinjection or infusion. The illustrative embodiments are with referenceto diabetes management using insulin therapy. It is to be understoodthat these illustrative embodiments can be used with different injectionand infusion devices and related products, as well as for different drugtherapies and regimens for other medical conditions besides diabetes.

Drug Delivery Pens and Vials

Medication delivery pens are used for self-injection of preciselymeasured doses of medication. Pens are widely used, for example, bydiabetics to self-inject insulin. A typical medication delivery penincludes a cartridge which contains a volume of liquid medicationsufficient for several doses. Using a disposable pen needle attached tothe pen device, the dose is injected into a tissue area, such as theintramuscular tissue layer, the subcutaneous tissue layer, or theintradermal tissue layer.

The assembly and operation of a typical pen injection device isdescribed in commonly-assigned U.S. Pat. No. 7,645,264, which is herebyincorporated by reference in its entirety.

Pen injection devices, such as an illustrative drug delivery pen or peninjector or injection pen 50, as shown in FIGS. 1 and 2, typicallycomprise a dose knob/button 24, an outer sleeve 13, and a cap 21. Thedose knob/button 24 allows a user to set the dosage of medication to beinjected. The outer sleeve 13 is gripped by the user when injectingmedication. The cap 21 is employed by the user to securely hold the peninjector 50 in a shirt pocket, purse, or other suitable location.

FIG. 2 is an exploded view of the illustrative drug delivery pen 50shown in FIG. 1. The dose knob/button 24 has a dual purpose and is usedto both set the dosage of the medication to be injected and to injectthe dosed medicament via a lead screw 7 and stopper 15 from a medicamentcartridge 12, which is attached to the drug delivery pen through a lowerhousing 17. The medicament cartridge 12 is typically a glass tube sealedat one end with a septum 16 and at the other end with the stopper 15. Instandard drug delivery pens, the dosing and delivery mechanisms are allfound within the outer sleeve 13. Those mechanisms are not described ingreater detail herein as they are understood by those knowledgeable ofthe art. A pen needle assembly 10 includes a hub 20, a patient needle 11extending from a patient end of the pen needle assembly, and aseptum-penetrating needle cannula 18 disposed within the hub 20 on anon-patient side thereof. The septum-penetrating needle cannula 18 is influid communication with the patient needle 11. The hub 20 is typicallyscrewed onto the lower housing 17. In attaching the hub 20 to the lowerhousing 17 or directly to the medicament cartridge 12, theseptum-penetrating, cannula 18 pierces the septum 16. The distalmovement of the plunger or stopper 15 within the medicament cartridge 12(due to advancement of the lead screw 7) causes medication to be forcedinto the patient needle 11 of the hub 20. To protect a user, a rigidouter shield 29 attaches to and covers the hub 20. The outer shield 29can also be used as a handle or grip to screw hub 20 onto or off of peninjector 50. An inner shield or needle cover 28 covers the patientneedle 11 within the outer shield 29.

FIG. 3 illustrates a schema for varying the location of an injectionsite. More specifically, a pattern 40 for injections within a body areacan be, for example, an imaginary clock face 40 on the user's abdomen32, and the user varies the injection site like the hour hand of theclock, for example, moving from 12 o'clock for one injection to oneo'clock for the next injection and so on. The clock face can be centeredon the user's umbilicus (i.e., belly button). Alternatively, theabdominal area of the body can be divided into different types of zonessuch as using compass zones (e.g., N, NE, E, SE, S, SW, W, and NW).Patterns 40 for dispersing injection sites on the abdomen can also beaccomplished using concentric circles, as shown in FIG. 24, or dividingthe abdominal area into designated areas such as quadrants as shown inFIG. 23B and then employing a pattern 40 within each designated area(e.g., quadrant) such as a matrix or grid pattern or a spiral pattern asdepicted in FIG. 23B.

According to one embodiment, a reminder system to aid a user in varyingthe location of an injection site includes an indicator, such as ahollow indicator sleeve 60, as shown in FIG. 4. The indicator sleeve 60has indicia 62 thereon related to a plurality of injection sites. Morespecifically, the indicator sleeve 60 has numbers 1-12 corresponding tohours on a clock face, such as the imaginary clock face in FIG. 3.According to one embodiment, the indicator sleeve 60 is a flexible ringthat can fit around another object, such as an injection pen, aninjection pen cap, or a medicament vial. It is to be understood that thering can be provided with different indicia to accommodate differentinjection regimens such as the afore-mentioned compass zones, or indiciarepresenting different quadrants or sites on two or more concentriccircles imagined or placed around the umbilicus, or number of days(e.g., 1-7, or abbreviations for the days of the week), or coordinatesfor a grid, or other indicia that represent a pattern of injections andthat may vary depending on which body area(s) is used.

As shown in FIG. 5, the indicator sleeve 60 is rotatably disposed aboutthe injection pen 50. For example, the sleeve 60 can be a flexible ring(e.g., made of rubber or other flexible material) that can be continuousor have a space along its circumference and can accommodate differentsizes of pen housings. The sleeve 60 is provided with indicia 62corresponding to a target injection site pattern or grid (e.g., numerals1 through 12 representing a site rotation plan that employs a clockpattern or compass coordinates such as N, NE, E, SE, S, SW, W, and NW)to be employed in a selected body area. The indicia 62 can be alignedwith the dose window. Alternatively, in addition to a dose window 30used for setting a dose, the injection pen 50 can also include a siteindicator 64, such as an arrow fixedly disposed on the injection penbody. According to one embodiment, the site indicator 64 is a separatepiece adhered to the outer sleeve 13. One skilled in the art, however,will appreciate that the site indicator 64 can be, a raised or recessedfeature molded into the outer sleeve 13, a marking, or other indiciawithout departing form the scope of the present invention. According toone embodiment, the outer sleeve 13 and the indicator sleeve 60 includedetents to provide the user with tactile feedback to indicate revolutionof the indicator sleeve 60 corresponding to the advancement of a singleindicium. The detents can also provide audible feedback, such as aclick.

To use the reminder system illustrated in FIG. 5, before or after givingthe injection at the site on the abdomen or other body area thatcorresponds to the indicium 62 aligned with the site indicator 64, theuser manually rotates the indicator sleeve 60 so that the nextconsecutive indicium is aligned with the site indicator 64. Thus, priorto the next injection, the user can be reminded of the site for the nextinjection, and by varying the site, can reduce the likelihood ofdeveloping lipodystrophy. Use of this embodiment is simple, easy toremember, and can work on any injection pen, such as an insulin pen.Alternatively, the indicium can be advanced automatically, for example,as shown in FIGS. 22A through 22C and described below.

FIG. 6 illustrates another embodiment in which the indicator sleeve 60is secured to the outer sleeve 13, and a window sleeve 66 having awindow 68 is rotatably disposed about the outer sleeve 13. According toone embodiment, the indicia 62 are spaced and the window 68 is sized sothat only one indicium is visible through the window at a given time.Use of this embodiment is similar to that of the FIG. 5 embodiment,except that instead of rotating the indicator sleeve 60, the userrotates the window sleeve 66. According to one embodiment, the windowsleeve 66 and at least one of the outer sleeve 13 and the indicatorsleeve 60 include detents to provide the user with tactile feedback toindicate revolution of the window sleeve 66 corresponding to theadvancement of a single indicium. The detents can also provide audiblefeedback, such as a click.

In addition to a sleeve, an indicator in accordance with anotherillustrative embodiment of the present invention can be a wheel or discwith indicia on a face of the disc. In one embodiment, the disc isrotatably mounted in conjunction with a fixed site indicator. In use,the disc is rotated to align the next indicium with the site indicatorsubsequent to injection. According to one embodiment, the site indicatoris an arrow. According to another embodiment, the fixed site indicatoris a window, through which a single indicium is visible at a given time.

In addition to a single indicator, embodiments of the present inventioncan include and additional indicator. For example, as shown in FIGS. 7and 8, a reminder system 70 includes an indicator 72 with indicia 74related to injection sites in combination with an additional indicator76 that has indicia 78 related to days of the week. Alternatively,indicator 76 could have indicia 78 to indicate days of the week inaddition to a time of the day. FIG. 7 illustrates the reminder system 70disposed on a medicament vial 80, and includes a site window 82 and aday window 84.

The indicator 72 is a disc with teeth 86 disposed circumferentially allaround the disc, and the additional indicator 76 is a disc with only afew teeth 88 circumferentially disposed. The additional indicator 76 isa lost-tooth gear, as best shown in FIG. 8. For clarity, most of theteeth 86 on the indicator disc 72 are omitted in the figure. Inoperation, the teeth 88 only engage the teeth 86 during part of therotation of the additional indicator 76. Thus, during one full rotationof the additional indicator (all seven days of the week) 76, the teeth88 only engage the teeth 86 to advance the indicator 72 by a singleindicium 74. As stated herein, other indicia can be used depending onthe desired shot regimen and injection site rotation plan. Also, thereminder system 70 can be used on other drug delivery products such ason a package of syringes or vials, or as a separate handheld device thatis apart from a vial or pen (e.g., a portable counter that can have aform factor like a credit card for storage in a wallet or purse or foruse as a refrigerator magnet).

In addition to representing sites around the abdomen (e.g., numerals 1,2, . . . , 12 as described with FIG. 4), indicia 74 on the indicator 72can represent injections sites at different locations on the body. Forexample, as shown in FIG. 8, the indicia 74 on the indicator disc 72represent three general locations (A—abdomen, T—thigh, and B—buttocks),as well as four subdivisions (left (L), right (R), upper (U), and lower(L)) within the general locations as indicated in the following table.

TABLE I Illustrative injection site rotation scheme Body Area Body AreaZone 1 2 3 4 5 6 7 Abdomen (Left) Upper Abdomen (Right) Upper Abdomen(Left) Lower Abdomen (Right) Lower Thigh (Left) Upper Thigh (Left) LowerThigh (Right) Upper Thigh (Right) Lower Buttocks (Left) Inner Buttocks(Left) Outer Buttocks (Right) Inner Buttocks (Right) OuterThus, in this example, the indicia 82 are related to twelve injectionsites at different locations on the body.

FIG. 9 illustrates a lost-tooth sleeve 90 that can be employed inembodiments of the present invention. In embodiments in which the losttooth sleeve 90 is employed with a disc indicator, such as indicator 72with gear teeth 86 disposed circumferentially all around the disc, thesleeve 90 rotates about a first axis (e.g., a longitudinal axis of amedicament bottle, an injection pen, or an injection pen cap) and thedisc indicator 72 rotates about an axis that is substantiallyperpendicular to the first axis. In this manner, during a completerevolution of the sleeve 90, the tooth 92 only engages the teeth 88sufficiently to advance the indicator 72 by a single indicium. In suchan embodiment, the windows 82 and 84 can be arrayed vertically, ratherthan the horizontal disposition illustrated in FIG. 7.

In addition to being employed with an indicator disc, in embodiments ofthe present invention, a lost-tooth sleeve can be employed with anindicator sleeve. FIG. 10 is an exploded, perspective view illustratinga hollow indicator sleeve 100, a wave spring 106, and an additional,hollow, lost-tooth sleeve 110 in accordance with an embodiment of thepresent invention. The indicator sleeve 100 has a plurality of indicia102 relating to a corresponding plurality of injection sitescircumferentially arrayed around the sleeve 100. Additionally, theindicator sleeve 100 includes a distal flange 103 and a plurality ofgear teeth 104 disposed on a proximal end thereof. The additional,lost-tooth sleeve 110 includes a gear tooth 112 disposed at a distal endthereof, a plurality of indicia 114 corresponding, for example, to daysof the week, a user interface 116, and a follower 118 that will besubsequently explained in greater detail.

The wave spring 106 includes a gap 108 that surrounds the tooth 112, andis disposed between the indicator sleeve 100 and the additional sleeve110 to bias the additional sleeve distally. According to one embodiment,a single one of the indicator sleeve indicia 102 and a single one of theadditional sleeve indicia 114 are visible at a given time through awindow or a plurality of windows on a device, such as an injection penor an injection pen cap (see, for example, FIG. 13).

As shown in FIGS. 11 and 12, an injection pen 120 has a retaining track122 for rotatably retaining the distal flange 103 of the indicatorsleeve 100 and substantially preventing axial displacement of the sleeve100 relative to the pen 120. One skilled in the art will appreciate thatthe flange could be disposed on the interior of the pen and acorresponding retaining track could be disposed on the indicator sleevewithout departing from the scope of the present invention. The pen 120also has a cam track 124 for guiding the follower 118.

The cam track 128 includes a first portion 126 that guides the follower118 (and thus the lost tooth sleeve 110) in a substantially planarmanner. While the lost tooth sleeve 110 is rotating with the followerdisposed in the first portion 126, the bias of the wave spring 106prevents the lost tooth sleeve 110 from contacting the indicator sleeve100. In other words, the bias of the wave spring 106 prevents theadditional sleeve gear tooth 112 from engaging the indicator sleeve gearteeth 104 when the follower 118 is travelling in the plane defined bythe first portion 126 of the cam track 124. In contrast, when thefollower 118 travels in a second portion 128 of the cam track 124, thefollower 118 (and thus, the lost tooth sleeve 110) overcomes the wavespring bias, displaces distally, and the gear tooth 112 engages one ofthe gear teeth 104. Upon continued rotation of the lost tooth sleeve110, because of the engagement of the gear teeth, the lost tooth sleeve110 advances the indicator sleeve 100 by a single indicium, the gearteeth disengage, and the follower returns to travelling in the firstportion 126 of the cam track 124.

Although a single follower 118 and single second portion 128 areillustrated for clarity, one skilled in the art will appreciate that aplurality of followers 118 and a corresponding plurality of secondportions 128 can be employed without departing from the scope of thepresent invention, and can enhance the stability of the additionalsleeve's travel, and provide a smoother path as well. For each follower,there is a corresponding plurality of indicia. For example, in anembodiment with two followers 118 and two second portions 128, two weeksof indicia are arrayed around the lost-tooth sleeve 110. In such anembodiment, one half of a rotation of the lost-tooth sleeve 110 passesthrough a week and advances the indicator sleeve 100 by a singleindicium. One skilled in the art will also appreciate that thefollower(s) can be disposed on the interior of the pen and acorresponding cam track could be disposed on the additional orlost-tooth sleeve without departing from the scope of the presentinvention. One skilled in the art will also appreciate that additionalsleeves can be disposed on the device with a corresponding cam track toindicate a third set of indicia.

According to one embodiment, advancing the lost-tooth sleeve 110 by asingle indicium generates audible and/or tactile feedback for the user.One skilled in the art will appreciate that any number of mechanisms canbe employed to provide such feedback without departing from the scope ofthe present invention. Additionally, such mechanisms can aid in moreprecisely positioning indicia adjacent to a viewing window. Mechanismssuch as odometer-type mechanisms employing an additional gear could beutilized to provide the intermittent motion of the second and subsequentrings.

For example, the lost-tooth sleeve 110 and related mechanical componentsillustrated in FIGS. 10-12 for advancing the indicator sleeve 100 can bereplaced by an electronic display 214, and electromechanical and/orelectronic means can be used in the pen for tracking injection sites(e.g., whenever the user interface is turned or pushed prior to aninjection) and providing microswitch 210 output signals to the display214 (e.g., having an integrated controller) or a separated processor(not shown) connected to the microswitch and the display, as illustratedin FIGS. 22A through 22C. The casing of the pen 120, for example, can beprovided with a microswitch 210 on its interior that operates inconjunction with an actuator 212 provided on the user interface 116 or aplunger, which can be an indentation or groove or other means to providea force to a button or lever on the microswitch 210 each time the pen isused for an injection. In response to movements of the user interface116 and corresponding activations of the microswitch 210, previousinjections sites can be tracked (or at least counted), and a display 214can be controlled to change whenever the next injection site needs to bedisplayed in accordance with a selected site rotation plan (e.g., showone of the 12 locations in Table 1 and a corresponding day of the week,or show a number 1 through 12 representing injection locations aroundthe umbilicus). The display 214 can be one or more display screens orwindows in the casing of the pen. Alternatively, the microswitch 210 orother electronic or electromechanical means for advancing the displaycan be provided on the outer surface of the user interface 116 thatslidably engages the interior of the pen 120, and the aforementionedcorresponding actuator 212 can be provided on the interior of the pencasing.

FIG. 13 illustrates a reminder system similar to that shown in FIGS.10-12, except that it is inverted and disposed in an injection pen cap130. The cap 130 includes windows 132 and 134 for viewing the indicia102 and 114. The user interface 116 extends from the proximal end of thecap 130. Alternatively, the cap can be provided with electronic orelectromechanical means (e.g., a microswitch 210 on the outer surface ofthe pen that slidably engages the interior of the pen cap), and theaforementioned corresponding actuator 212 provided on the interior ofthe pen cap) to cause changes to the display(s) 102 and 114 inaccordance with a selected site rotation plan. Alternatively, thelocations of the microswitch 210 and actuator 212 can be reversed (e.g.,the actuator on the outer surface of the pen that slidably engages theinterior of the pen cap, and the corresponding microswitch on theinterior of the pen cap).

With reference to FIG. 22C and in accordance with illustrativeembodiments of the present invention, the display 214 on the pen cap 136can indicate a target injection site that is automatically advanced upondetection of the pen being recapped. For example, the display 214 canindicate “SITE 1” according to a selected site rotation plan. After thecap 136 has been removed and an injection made, the pen 120 is recapped.The operation of the microswitch 210 and actuator 212 provided onrespective ones of the pen cap 136 and the exterior of the pen casingcause the display 214 to be automatically advanced to indicate the nexttarget injection site “SITE 2”. Other displayed indicia can be used torepresent the next target injection site based on the injection rotationplan used by the patient. The pen 120 can be pre-configured orconfigurable to display target injection sites in accordance with adesignated injection site rotation plan and indicia representing thetarget sites.

FIG. 14 illustrates another illustrative embodiment of a reminder systemin an injection pen cap 136. The cap 136 is similar to the cap 130 inmany respects; for example, the user interface 116 extends from theproximal end of the cap 130, and the window 134 displays the indicia onthe lost-tooth sleeve 110. In contrast, however, the cap 136 includes aplurality of windows 138 that graphically correspond to body areas forinjection, and rather than being alpha-numeric, the indicia 140 on thehollow indicator sleeve are simply a shaded or colored area. Inoperation, rotation of the lost-tooth sleeve 110 through a set ofindicia (for example, one week), advances the indicator sleeve toindicate a different body area. For example, the shaded or coloredindicia 140 could advance from a window 138 representing the right,upper abdomen to a window 138 representing the left, upper abdomen.

Such an embodiment can reduce the number of indicia on the indicatorsleeve, depending on the sequence of body areas, because the sameindicium can be used in at least two windows. For example, for thewindows representing the front of the body, a single indicium 140 can bevisible through a window 138 representing a given right body area (upperabdomen, lower abdomen, upper thigh, or lower thigh), and then, uponcounter-clockwise rotation of the lost-tooth sleeve 110 and advancementby the selective contact between the tooth 112 on the lost tooth-toothsleeve 110 and the teeth on the indicator sleeve, the same indicium 140can be visible through the window 138 representing the correspondingleft body area (upper abdomen, lower abdomen, upper thigh, or lowerthigh). Further, assuming a sequence of buttocks areas of outer right,inner right, inner left, and outer left, a single indicium 140 can besequentially visible though the corresponding windows 138. One skilledin the art will appreciate, however, that other body area sequences canbe employed without departing from the scope of the present invention.Additionally, the display may be implemented electronically.

Similar to the reminder system shown in FIGS. 10-12, FIG. 15 illustratesa reminder system 142 disposed on a medicament vial 144. Such anembodiment can be useful for patients that use syringes and a medicamentvial rather than an injection pen. According to one embodiment, thereminder system 142 is fixedly secured to the medicament vial 144.According to another embodiment, the reminder system 142 can be removedfrom the vial 144 and attached to another vial to be re-used.

The reminder system 142 includes housing 146 with windows 148 and 150for viewing the indicia 152 and 154 on the hollow indicator sleeve andthe hollow, additional or lost-tooth sleeve, respectively. In use,similar to the reminder system shown in FIGS. 10-12, the user rotates auser interface 156 to sequentially show the indicia 154 through thewindow 150, and upon a complete cycle of the indicia 154, the indicatorsleeve is advanced to show the next sequential indicium 152 through thewindow 148.

FIG. 16 illustrates a hollow indicator sleeve 160 in accordance with anembodiment of the present invention. The indicator sleeve 160 includes aplurality of indicia 162 arrayed circumferentially, and a correspondingplurality of radial protrusions 164 arrayed circumferentially. The spacebetween adjacent radial protrusions 164 forms a slot 166. According toon embodiment, the radial protrusions 164 are substantially trapezoidal,having a first angled surface 168, a second angled surface 170, and apair of parallel sides 172 and 174 that are substantially aligned withthe longitudinal axis of the hollow indicator sleeve 160.

FIG. 17 is a partial, cross-sectional, schematic view of an injectionpen 180 incorporating the indicator sleeve 160. The pen 180 includes amedicament cartridge 182 and a dosing mechanism 184, both of which areshown schematically for clarity. The pen 180 also includes an outer case186 and an injection button 188 for setting the dose (in conjunctionwith the dosing mechanism 184) and injecting the medicament.

The outer case 186 includes a proximal flange 190 that prevents theindicator sleeve 160 from proximally exiting the pen 180. The case 186also includes a shelf 192 that protrudes radially inward and supports abiasing element (such as a spring) 194, which proximally biases theindicator sleeve 160. In addition, the case 186 includes a primaryadvancing protrusion 198 (shown in FIG. 17) and a secondary advancingprotrusion 200 (shown in FIGS. 18-21), which are circumferentially andaxially offset form each other. Further, both advancing protrusions 198and 200 protrude radially inward.

Referring to FIGS. 16-21, as the user depresses the button 188 distally,a button flange 202 engages the proximal end of the indicator sleeve 160to displace the indicator sleeve 160 distally and overcome the force ofthe biasing element 194. For illustrative purposes, in FIGS. 18-21, twoadjacent indicator sleeve radial protrusions 164 are referred to asprotrusions 164A and 164B. As the first angled surface 168A of theprotrusion 164A is displaced distally, it engages and slides against theproximal angled surface 204 of the primary advancing protrusion 198(FIGS. 18 and 19), to rotate the indicator sleeve 160 and align a slot166 with the primary advancing protrusion 198 (FIG. 20).

Subsequently, once the user releases the button 188 after finishing theinjection, the biasing element displaces the indicator sleeve 160proximally. During this proximal displacement (FIGS. 20 and 21), thesecond angled surface 170A engages and slides against a distal angledsurface 206 of the secondary advancing protrusion 200, to further rotatethe indicator sleeve 160. This further or secondary rotation of theindicator sleeve 160 aligns the next indicium 162 with a viewing window(not shown), and aligns the adjacent protrusion 164B, so that upon thenext depression of the button 188, the first angled surface 168B willengage and slide against the proximal angled surface 204 of the primaryadvancing protrusion 198 (FIG. 21).

The embodiment shown in FIGS. 16-21 can be useful for changing the bodyarea for each injection. Additionally, by repeating indicia 162, aparticular body area can be visible through the viewing window for agiven number of injections before a different body area is visiblethrough the viewing window. A similar sequential advancing mechanism isdescribed in commonly-assigned U.S. Pat. No. 7,597,853, which is herebyincorporated by reference in its entirety.

As exemplified herein, illustrative embodiments of the present inventionprovide users of injection pens or vials with different injection sitetracking and/or reminder methods and apparatuses to recollect where thelast injection was administered and/or be advised where to locate thenext injection site, or when to rotate to a new body area and/or bodyarea section or zone.

Single Dose Syringes or Vials or Other Devices and Related Packaging

Many diabetic patients choose to administer their insulin usingdisposable, pre-measured single dose syringes, or single or multipledose vials of insulin for use with a pen needle assembly. Example pensare illustrated in FIGS. 1-2 as described above. The followingillustrative embodiments help patients follow an injection site rotationplan using the insulin product packaging such as boxes, cartons or othercontainers comprising disposable supplied such as pen needles, unit dosesyringes or vials.

In one embodiment of the invention, the packaging for the insulindelivery devices provides instructions and recommended guidelines toassist the patient in selecting a body area and/or an injection sitewithin the body area to reduce the risk of lipohypertrophy. Thepackaging can have a variety of forms and shapes with preprinted labelsor indicia on the cover, or other surfaces of the packaging for theinsulin delivery devices, or as a printed insert placed in or on thepackaging, or on each of the insulin delivery devices stored within thepackaging. The packaging typically contains a number of insulin vials,ampoules, prefilled syringes, injection pens or other single use insulindelivery devices. Indicia on the insulin delivery devices are preferablycoordinated with the packaging to encourage rotation and relocation ofthe body area injection site to reduce the occurrence of repeatedinjection in the same or similar area or injection site of the patient.It is generally recommended that sequential injection sites be spacedapart a distance sufficient to reduce the risk of lipohypertrophy (e.g.,1-2 centimeters apart, or one to two finger widths apart).

Referring to the drawings, a package can be produced for shipping andstoring insulin vials, ampoules or other single use delivery devices. Inthe embodiment shown in FIGS. 25A and 25B, the package 220 is a boxhaving a lid 222 or other surface which can have instructions in theform of printed indicia providing the instructions, guidelines andrecommendations for the rotation of injection sites within a body area.In the embodiment shown, the instructions can be preprinted on a surfaceof the package such as on the interior of the lid 102 or on a side 104of the package. Instructions can be, for example, all or part of theinstructions illustrated in FIGS. 40A through 40F, or indicia orpatterns (e.g., different colors and/or shapes) on the package box 220and stickers or labels on individual delivery devices (e.g., penneedles, vials, syringes) 228 stored in the box 220 that correspond tobox compartments 226, or chart or other storage arrangement tofacilitate reminding a user to rotate or otherwise intersperse injectionsites within a body area and/or among plural body areas each time adelivery or injection device 228 is removed from the package 220 foruse.

The package 220 in the embodiment shown is divided into fourcompartments 226 for storing and shipping the insulin injection devices228 (e.g., vials, single dose syringes, pen needles, and so on). It isto be understood that the compartments can be separated by physicaldividers 229 in the package, or on the basis of coding of the packaging220 and/or the devices 228. Each compartment 226 can contain the same ora different number of the insulin delivery devices 228. The compartmentsare identified according to the location of a recommended body area orthe injection site within a body area on the patient according to theinjection protocol. The compartments 226 have suitable indicia 230 orother visual indicator corresponding to a predetermined body area orinjection site on the patient. The compartments 226 can be color codedas shown with different colors or hues or printed patterns that enablethe patient or technician to quickly and easily select an insulindelivery device 228 by color for a designated body area or targetinjection site corresponding to that color. The individual compartments226 and the insulin delivery devices 228 can have coordinating colorsand/or labels 232 so that the insulin delivery device 228 has the sameidentifying indicia, color or markings as the corresponding compartment226 in which it is stored before use. In the embodiment shown, each ofthe compartments 226 has a different color such as for example red,blue, green and orange. Preferably, the colors and shades are selectedto be visually distinguishable to the average user and color blindusers.

The compartments 226 with the insulin injection devices 228 and thecorresponding colors are preferably designated to correspond to adifferent body area or region on the patient such as, for example, theabdomen 32, one or both legs or thighs 34, one or both buttocks 36, orone or both arms 38, or to any other suitable area on the patient, asillustrated in FIGS. 23A and 23B. The different compartments 226 of thepackage 220 can also be identified by distinctive markings 230 such as ageometric shape or design assigned to either a body area or theinjection site within the body area. Preferably, each insulin injectiondevice 228 includes the same or similar markings corresponding to thedesignated compartment 226 in the package 220 in which it is stored orotherwise contained. In the embodiment shown, the four compartments 226include markings 230 identified by an X, circle, square and a triangle,although other shapes and designs can be used either alone or incombination. Preferably, each of the individual insulin injectiondevices 228 includes a label 232 as shown where the label is color-codedand includes one of the geometric design markings 234 corresponding tothe respective marking 230 of the compartment 226 in which the device228 is stored prior to use. The labels 232 are preferably attached tothe individual insulin injection device 228 or a container for theinsulin delivery device by an adhesive. In one embodiment, the adhesiveis a pressure sensitive adhesive that allows the label 232 to be removedand reapplied as needed.

During use, the patient identifies each of the colors and geometricmarkings as corresponding to a selected body area or injection site ofthe patient for injecting the insulin. The patient is able to select aninsulin injection device 228 from a particular compartment 226 tomonitor the number of injections in the particular injection site orbody area and to encourage selecting an alternate injection site or bodyarea to avoid repeated injection within the same body area or injectionsite. As each of the insulin injection devices 228 are used anddiscarded, the remaining insulin injection devices 228 within thepackaging 220 and the respective compartments 226 provide an indicationor record of the number of injections in the particular injection areaor injection site identified by the color and/or marking 234.

With reference to FIG. 37, a mobile phone app can also be provided fordownloading onto a user's phone and used in conjunction with the codingscheme of the packaging 220 as described below.

In another embodiment the package 220 can include indicia and/or colors230 to identify a specific body area, such as for example, the legs,arms, and abdomen. The packages 220 can contain a plurality of insulininjection devices 228 having various markings for identifying specificinjection sites within the body area. In the embodiment as shown in FIG.25B, the packaged insulin injection devices are positioned in rows andcolumns by dividers within the package 220. The injection devices can bealigned in a row corresponding to a particular day of the week, forexample. The columns can correspond to the number of injections per day,for example, and can include indicia corresponding to the recommendedinjection site to provide the desired rotation or sequential movementand relocation of the injection sites. Different configurations forarranging injection devices 228 within the compartments 226 or simplywithin the package 220 (e.g., rows and columns) can be used tofacilitate guiding a user to employ a particular device 228 at aselected injection site within a selected body area at a designated dateand/or time (e.g., different numbers of compartments, and/or rows andcolumns, depending on the injection regimen).

In another embodiment shown in FIG. 26, the package 240 is divided intoseparate compartments or sections 242 configured to each receive orotherwise store a delivery device (e.g., pen needles or ampoules whichare not shown) 228 such that the devices are arranged corresponding to aselected pattern of injection sites. For example, with reference toFIGS. 3, 24 and 29 where the abdomen 32 is the designated body area toreceive injections, the regimen may require dispersing injection sitesalong radii of one or more concentric circles centered on the umbilicus42. The radii can correspond to the hours of a clock or compass zones orother pattern. As shown, the compartments 242 are identified by indiciaor markings 244 (e.g., numbers 1 through 12 corresponding to the hourson clock) depicting the recommended location for the injection site toencourage rotation and selection of a different injection site for eachsubsequent insulin injection by simply removing the device from acompartment and administering the injection at a point on the abdomenthat is referenced relative to the compartment (e.g., the compartmentlabeled with “12” can be held at the top of the umbilicus 42 todetermine the injection site for the device in compartment currently inuse). The insulin injection devices (e.g., the pen needles or ampoules)228 can be optionally provided with a respective label that has the sameindicia or markings corresponding to the indicia 244 on the package 240for the respective compartments 242 in which the devices are stored orarranged.

In accordance with another illustrative embodiment shown in FIGS. 27Aand 27B, indicia or markings 250, 252 depict a specific injection sitewhich can be within a designated body area. The package 220 can bedesignated for a particular body area (e.g., the abdomen 32) so that thecompartments 226 and the respective indicia 230 correspond to therecommended sequential injection sites 252 within that body area 250. Inthe examples shown, the compartments 226 are given a marking 230 whichprovides a site map for an injection site 252 in a designated body area250 such as, for example, the abdomen 32. Similarly, the injectiondevices 223 stored in the respective compartments can be provided withlabels 248 or other medium having indicia (e.g., a site map) showing theinjection site 252 within the body area 250. The site map provided bythe indicia 230 and labels 248 divides the body area 250 into apredetermined number of segments corresponding to an identifiableinjection site 252. In the embodiment shown, the indicia or markings 250are a hexagon-shaped site locator map where each point corresponds to alocation around the abdomen 32 to identify an injection site 252. Eachpoint can be identified by a circle 252, color or other visual markingto identify the recommended injection site. In the embodiment shown, thepackage 220 has four compartments 226 so that four points are identifiedon the labels 248 corresponding to the injection site around theabdomen. The points on the hexagon can identify an injection site at anupper region, a lower region, a right side and a left side of theabdomen as shown in FIGS. 27A and 27B. The geometric shape can have thesame number of identifying locations 252 corresponding to the number ofcompartments 226 in the package. Although four compartments are shown,the package 220 can have six compartments 226 corresponding to thenumber of available injection sites or points on the indicia representedby the hexagon in the illustrated example. In another embodiment of theinvention, the package 260 as shown in FIG. 28 is provided with a chart262 printed on the package or as a removable card for recording andtracking the injection sites. By recording each injection site, thepatient is able to avoid or reduce the risk of injecting into the samesite repeatedly and select a different injection area or injection sitefor each subsequent injection. The patient can have a predeterminedorder or location of the injection sites that can be translated andrecorded onto the chart 262 to record the sequence, location androtation of injection sites. By way of example shown in FIG. 29, theabdomen 32 is the designated body area which can be divided into 12injection sites 272 representing a clock face where each imaginary clockface number is used to identify an injection site. Alternatively, theinjection sites 272 can be oriented as concentric circles as in FIG. 24.The chart 262 can be divided into a number of injection sites where eachspace 263 on the chart corresponds to the desired injection site. Theinsulin delivery devices 266 (e.g., pen needles 266 which can have acover 268), or packaging 264 for enclosing one of the individual insulindelivery devices 266 (e.g., with its cover 268), are provided with aremovable tab or label or sticker 270 to indicate the intended injectionsite. The tab or label 270 is removed by the patient at the time of useand attached to the chart 262 to provide a continuous record of theinjection sites. The label 270 can be printed with the recommendedinjection site or provided with a writing surface where the patient canwrite directly on the label to record the injection site, date, time orother desired information pertaining to the injection and the injectionsite. The label 270 is then attached to the chart 262 to record theinjection history.

For example, in one embodiment as shown in FIG. 28, the chart 142includes a plurality of spaces arranged in rows corresponding to theeven number and odd numbers of the image of the clock face on theinjection area of the abdomen. The injection site can be selectedcorresponding to an even number or an odd number of the image of theclock face and then the label 270 is removed from the insulin deliverydevice 266 and adhered to the chart 262 in a row corresponding to theeven number or odd number. The chart provides a visual record of thesequence of injection site locations. In other embodiments, the chart262 can be provided with a row or column corresponding to each of thenumbers of the clock face image or other pattern identifying theinjection sites of the designated injection area. The chart 262 can beprinted directly on the package such as on the inside surface of the lidor any convenient location that is accessible by the patient.Alternatively, the chart 262 can be separate from the package andcarried by the patient and stored in a selected location. The chart 262can have can have various rows and columns to identify the day of week,the body area of the injection, the injection site within the body areaand other information relating to the injection sites to assist thepatient in recording the previous injection sites and select aninjection she spaced from previous injection site a distance to preventinjecting in the same site.

Body Stickers

In accordance with illustrative embodiments of the invention, labels orstickers or other markers can be provided for adhesion to the patient'sskin at an injection site instead of to a chart (e.g., chart 262 in FIG.28). Thus, the user has an accessible visual record of previousinjections sites and guidance for locating target injection sites.

With reference to FIG. 30, an indicator 280 is provided which can beadhered to a patient's skin. The indicator 280 can be, for example, asticker with an adhesive backing for application to a user's skin. Thesticker can use a medical grade adhesive that allows the sticker toremain on for most user activities but also allows the sticker to beremoved when desired by the user.

The indicator 280 can be a multiple ply sticker, that is, where each ply281 is removably adhered to another ply 281 beneath it (e.g.,overlapping plies 281 a, 281 b, . . . 281 g). Each ply can be providedwith indicia (e.g., printed indicia on the ply, or a punched holethrough the ply) corresponding to respective site locations.

For example, the sticker 280 can be provided with a number and selectedarrangement of holes 282 that correspond to the grid or pattern ofinjection shots to be distributed to the body area beneath the stickerwhen it is adhered to the skin of the user. For example, the sticker 280can define a circular distribution area for injection sites with sevenholes 282 arranged in a circle. The arrangement of the holes 282 can beidentical on each ply 281, and the plies 281 aligned with respect toteach other, so as to align the holes of each ply and accommodate theinsertion of needle or catheter of the drug delivery device in thealigned holes and into the injection site underneath.

With continued reference to FIG. 30, each ply 281 provided with aprinted indicia 284 with respect to one of its holes to represent atarget hole 282 and corresponding target injection site associated withthat ply. The printed indicia 284 is associated with a different one ofthe holes 282 in each ply 281. Once an injection is administered throughthe hole with printed indicia 284 in the top most ply, that ply isremoved before the next shot. The underlying ply 281 then guides theuser to next inject via a different hole as indicated by itscorresponding printed indicia.

The number of plies 281 in a sticker 280, and the number of holes 282 ineach ply 281 can differ, depending on the injection regimen andinjection site rotation plan. Further, the arrangement of holes 282 andor printed indicia 284 on each ply 281 can vary depending on the desiredinjection site distribution pattern (e.g., sites arranged in a grid ormatrix, or sites spaced apart from each other along a circle or spiralline) for the body area beneath the sticker 280 when adhered to theuser's skin. The numbers of plies and holes and the arrangement of holesand indicia can be arranged to adhere to a prescribed shot regimen thatminimizes lipodystrpohy in the tissue underneath the sticker 280.Preferably, the plies underneath the indicated hole 304 have acorresponding void to allow an injection needle to access to the skin.

In accordance with another embodiment of the present invention, separatestickers can be provided for respective target injection sites asillustrated by each sticker 285 shown arranged in a designated pattern(e.g., a circle) in FIG. 30B. The respective stickers 285 can bearranged around the umbilicus 42 on a patient's abdomen 32, for example,as shown in FIGS. 29 and 30C. It is to be understood that the stickerscan be arranged in other patterns (e.g., in a matrix or grid, ordispersed or spaced along a spiral 40 as shown in FIG. 23B or other typeof path) on other body areas (e.g., the thighs, arms or buttocks). Thespacing of the stickers can be selected so that the sites directly underthe stickers are spaced to 2 cm or other distance apart to prevent orreduce lipodystrophy.

A template can be provided with the stickers 285 to guide theirplacement on the patient's body area. A template can be a sheet ofmaterial with suggested pattern, or a sheet on which the stickers 285are temporarily adhered (e.g., via double-sided adhesive) such that theycan be rubbed onto or otherwise transferred to the patient body area inthe pattern indicated on the template.

Alternatively, with reference to FIGS. 30D and 30E, a larger sticker 288that comprises apertures 290 arranged in a pattern for injection siterotation can be used instead of a plurality of individual stickers 285,each sized for designating a single injection site. The apertures 290can each be covered by an individual adhesive cover 294 that is removedprior to an injection at the body area site surrounded by an aperture290 in the sticker 288. Thus, the covers 294, or lack thereof at atarget site or aperture 290 serves as a visual reminder of whereinjections have already occurred. The apertures 290 can be dimensionedto have a diameter large enough to receive a needle. Alternatively,depending on the material of the sticker 288, no aperture 281 isprovided, but rather indicia 292 are used to indicate a target site, anda user plunges a needle through the sticker material to inject into thebody area beneath the indicia 292. This arrangement can also be usedwith a multi-ply sticker 280 wherein no holes are provided but ratherindicia for guiding the penetration of one or more plies represents thetarget injection sites. If apertures 290 are provided in the sticker,the indicia 292 can still be provided around the aperture 290 as avisual guide for the user to that corresponding target site. Inaddition, pattern indicia 296 can be provided as a visual guide to theuser to inject in the target sites using an order indicated by thepattern indicia. The pattern indicia 296 can be arrows between targetsites 290, or numbers, lettering or other graphic provided on thesticker 288 next to or on the target sites 290 (e.g., if no aperture isprovided), or on the covers 294 of apertures 290.

Regardless of whether stickers are multi-ply stickers 280 or individualstickers 285 per target site, or a sticker 288 comprising a pattern oftarget sites, the stickers can be made for example, from an adhesivestrip with printed indicia that is applied to a patient's skin andremains until a user manually peels off the strip. Alternatively, thesticker 295 and 288 can be implemented using a material which is similarto a temporary tattoo, that is, the sticker is applied to a patient'sskin and remains on his skin until removed with an alcohol swab. Sincealcohol can be used to prepare a target site for injection, the alcoholswab can also wipe off the corresponding tattoo for that next injection.

Thus, the sticker 280, 285, 288 provides a simple mechanism by which auser can track past injection sites and an indication of where the nexttarget injection site is located.

Optical Mouse Tools

In accordance with another illustrative embodiment of the presentinvention, an injection site locating device can be deployed that issimilar in operation to a computer mouse interface. With reference toFIG. 31, the injection site locating (ISL) device 300 can be a portable,handheld device that is part of, or separate from, an injection device(e.g., a CSII catheter or pen needle), or other medical device (e.g., acontinuous glucose monitor, or CSII pump), a mobile phone, or portablecomputing device (e.g., a personal data assistant (PDA), laptop, tablet,and so on), among other devices.

The ISL device 300 can be operated by a user (e.g., patient orcaregiver) moving the ISL device over (e.g., on or proximal to thesurface of) the target body area 302 of the patient 304. Using any ofseveral different types of computer mouse technology to track motion ofthe ISL device 300, a processor integral to the ISL device, or at leastcommunicatively coupled to the ISL device, can use the motion trackingto determine corresponding distances traveled by the ISL device over thebody area 302 and define position coordinates 306 (e.g., Cartesiancoordinates (x,y) or polar coordinates) of locations on the body area(e.g., coordinates for a target injection site or a past injectionsite(s)). For example, the ISL device 300 can track motion of the device300 relative to a reference point 308 (e.g., the umbilicus 42) in aselected body area 302 (e.g., the abdomen) to facilitate defining,storing and tracking coordinates of past injection sites, planned ortarget injection sites, or sites to be avoided such as lipodystrophicsites. It is to be understood that that ISL device 300 can be used withrespect to other body areas 302 (e.g., thigh, arm, buttock, and so on)and that other reference points 308 can be used (e.g., reference pointscorresponding to a naturally occurring feature on the body, artificiallyoccurring feature such as a tattoo or user's mark) that may varydepending on target body area 302.

For example, an ISL device can be provided with optical computer mousecomponents such as a light-emitting diode (LED) and corresponding imagesensor (e.g., a photodiode), that is, an optoelectronic sensor thatoperates as a low-resolution video camera to detect movement relative toa surface. The LED can be an infrared laser diode or a regular LED. Theoptical computer mouse components can be, for example, componentsdeveloped and commercially available from Agilent Technologies orLogitech International S.A.). As with an optical mouse, the injectionsite location device 300 employs a tiny camera to take pictures (e.g.,on the order of at least 1,500 pictures every second) as it traverses asurface such as a body area 302 being considered for a target injectionsite (i.e., that supports plural injection sites having medicallyacceptable spacing). The device 300 has a small, light-emitting diode(LED) for bouncing light off that body area surface 302 onto acomplementary metal-oxide semiconductor (CMOS) sensor. The CMOS sensor,in turn, sends each image to a digital signal processor (DSP) or otherprocessor in the device (or in another connected device) for analysis.The DSP detects patterns in the images and determines how those patternshave moved since the previous image. Based on the changes in patternsover a sequence of images, the DSP determines how far the ISL device 300has moved and sends the corresponding coordinates to the computer orother control device (e.g., programmed controller or ASIC) in the ISLdevice 300. The sensing and image storing and processing can beperformed via the same processor or different processors. Further, themotion tracking achieved via the image processing and the application ofthe motion tracking device to injection site tracking and monitoring canbe achieved via the same processor or different processors.

The ISL device uses the coordinates received from the imagesensor/processor to track, monitor and manage injection site rotation byproviding one or more functions, with associated feedback to the userincluding but not limited to:

-   -   site selection    -   site avoidance    -   site tracking and reporting (e.g., storing coordinates and dates        and times of each injection)    -   generation of reminders and incentives.

For example, the ISL device 300 can be programmed to store informationfor at least one injection site rotation regimen including informationregarding each body area 302 to be used for target injection sites 306,the frequency with which the body area 302 is used with respect to otherbody areas (e.g., a time period or total number of injections beforerotation to another body area is recommended), the time, date andcoordinates of past injection sites, the coordinates of injection sitelocations 306 and/or body areas 302 to be avoided and a correspondingtime period or other criteria that needs to be met before the site 306or area 302 can be used again for target injection sites, among otherinformation,

The ISL device 300 can be configured in accordance with software orusing an ASIC or FPGA to perform a number of operations such as siteselection. The ISL device can have an integral user interface or beconnected or wirelessly coupled to a device having a user interface. Theuser interface can be configured with a user input (e.g., button orswitch) to allow a user to select an initial body area 302 to receive aninjection and corresponding reference point 308. For example, a buttonon the ISL device 300 can be depressed by the user when the ISL deviceis centered over the umbilicus or other feature used as a referencepoint 308. The ISL device or connected device can have an output such asa display, or indicator (e.g., LED(s) illuminated and optionallyflashed), or audible sound generator to generate an indication of whenthe currently detected coordinate is acknowledged as the reference point308. Multiple presses of the button or other user input mechanism canallow for the user to scroll through a list of target body areas 302 ona display (e.g., a display that is integral to the ISL device 300 or ona connected external device) and to select one (e.g., depress the buttona selected number of times or for a selected duration such as for 2-3seconds).

Once the body area 302 and corresponding reference point 308 are set,the user can move the ISL device 300 over the body area toward a targetinjection site 306. Using motion tracking and stored data on pastinjection sites and sites to be avoided and regimen regarding when toselect a new body area 302, the target injection site can be evaluatedby the ISL device 300 and an indication generated (e.g., audible and/orvisual) when the target injection site is determined to be a valid site.The ISL device 300 then stores the coordinates for that injection site,as well as time and date. Evaluation and determination of validinjection sites can depend on a number of programmed and/or configurableparameters and criteria such as, but not limited to, permissibleproximity to adjacent past injection site (e.g., which can depend onbody area 302, amount of time that has elapsed since the injectionoccurred at the adjacent injection site, degree of lipodystrophypresented in the area, among other factors).

The ISL device 300 can also be configured to automatically determine(e.g., based on the above-referenced factors and stored data such aspast body area rotations and injection sites and stored regimen data)and output a suggested target site 306 to the user. The indication canoccur at the outset of the use of the ISL, or can occur in real-time asthe ISL is being moved about the body. For example, the ISL device 300can generate audible or visual indications of the suggested targetinjection site, or generate varying audible and/or visual indications asthe ISL device 300 approaches the suggested target site 306 when movedby the user.

As stated above, a number of different regimens can be implemented withvarying numbers of injections per day, or injections or infusions perweek, or a selected number of days, or target body areas, and so on.

Although the above illustrative embodiments of an ISL device 300 havebeen described using optical mouse technology, it is understood that amechanical mouse implementation (e.g., employing rotation of orthogonalshafts which drive chopper wheels for distance measurement) could beused. Such an implementation, however, could be somewhat difficult orless accurate given any unevenness of the surface of the body area 302over which it is used, which can vary significantly from body area tobody area and from patient to patient. Alternatively, the use of aninternal accelerometer to track the movements of the ISL about the bodyarea 302 can accomplish the same result.

Optical Projection Tools

In accordance with another illustrative embodiment of the presentinvention, an injection site projection device 400 can be deployed thatis similar in operation to a computer mouse interface. With reference toFIG. 32, the injection site projection (ISP) device 400 can be aportable, handheld device that is part of, or separate from, aninjection device (e.g., a CSII pump/catheter or pen needle), or othermedical device (e.g., a continuous glucose monitor), a mobile phone, orportable computing device (e.g., a personal data assistant (PDA),laptop, tablet, and so on), among other devices. For example, theinjection site projection device 400 can be located in the reusableportion of a patch pump for CSII. The patch pump can, in turn, be usedto project an image of a grid or other target image onto a body (e.g., apatient's abdomen) to help a user (e.g., the patient or a caregiver)locate a target injection site in the body area for attaching a catheterfor medicament infusions via the pump. The location of such a projectionfunction in the patch pump would be particularly convenient to such auser and can help guide the user to better distribute injection siteswithin an area.

The ISP device 400 can be operated by a user (e.g., patient orcaregiver) holding the ISP device 400 over a target body area 302 of thepatient 304. By configuring the ISP device 400 with any of severaldifferent types of handheld image projection technology, the ISP device400 can project a grid 402 onto the body area 302. The grid 402comprises a plurality of sections or sectors that represent different orrespective target injection sites. For example, the ISP device 400 canbe provided with a handheld projector (e.g., a pico projector or mobileprojector) to project a stored digital image of a grid 402 onto thesurface of a selected body area 302. The grid 402 has respective sectors404 that represent an injection distribution pattern for that body area402. It is to be understood that different grid patterns can be storedfor use on respective body areas 302. For example, a grid 402 for usewith respect to the abdomen may have a different overall size and/orshape than a grid 402 that is intended to be projected onto a thigh orthe buttocks. Further, the size and number of sections 404 in a grid 402can vary depending on which body area 302 or zone 406 of that area 302the grid is to be projected. For example, as shown in FIG. 32, the bodyarea 302 corresponding to the abdomen is divided into four zones 406 inaccordance with an example injection administration regimen. The samebody areas can be divided into different numbers of zones and locationsof zones, depending on a patient's preferred or prescribed medicamentadministration regimen and injection site rotation plan.

The ISP device 400 can be configured with a user interface that allows auser to input or otherwise select a body area and optionally a zone ofthat selected body area (e.g., outside of right thigh, or outer sectionof left buttocks, or right, upper quadrant of zone of abdomen). The ISPdevice 400 can be configured to project an image of the same gridregardless of the target body area 302, or select a grid image thatcorresponds to the target body area 302, or select from a plurality ofgrid images that are stored at the device 400 to accommodate differentpatients' medicament administration regimens and injection site rotationplans.

In a manner similar to the ISL device 300 described above, the ISPdevice 400 is configured to allow the user to select a reference point308 from which to project the image of the grid 402, or at least specifythe target body area 302 for which a default or automatically selectedreference point 308 is used as a point of origin from which the device400 can project the image of the grid onto the target body area. Theuser can employ a mobile app, or printed media (e.g., a calendar orprinted indicia on injection or infusion device packaging), or atemporary skin marker, or other apparatuses and methods described hereinto maintain a record of which sectors 404 of a grid 402 in a selectedbody area 302 and zone 406 have been used as injection sites.

Mobile Phone Applications and Tools

In another embodiment, a mobile device such is a cellular phone ormobile phone may be used to further enhance body area and injection sitediversity, that is, rotate injections among body areas, as well asdistribute injection sites within an area. FIG. 34 depicts anillustrative mobile phone running software according to an embodiment ofthe invention. As will be appreciated, the mobile phone includes animage sensor such as a camera, and preferably a front facing camera. Themobile phone further includes software and data storage adapted toperform functions to assist a user in tracking injections anddiversifying body area and injection locations within body areas. Themobile phone software utilizes the front facing camera and displays thecamera view on the display of the mobile phone, such that the user maypoint the front-facing camera at her body and view an image of thefront-facing camera view of her body with information preferablyoverlaid onto the provided view.

As shown in FIG. 33, a mobile device 3300 according to an embodiment ofthe present invention preferably includes a processor 3301, a memory3302, an image sensor 3303, a display 3304 preferably oriented on thesame surface of the device as the image sensor 3303, a housing 3305, anda user interface 3306. Memory 3302 preferably stores software to performrequired functions for assisting the user with body area and injectionsite diversity as discussed above. The memory further stores the usershot regimen, an injection site rotation plan, user injection data,injection site status data, and any other data necessary to performfunctions as discussed above.

The image sensor 3303 is preferably a camera such as those provided onmost mobile devices. The image sensor provides image data to theprocessor 3301 and/or the memory 3302 in order to perform the functionsdescribed above, and to be described in further detail below. The imagesensor 3303 may further be a specialized image sensor to provideadditional functionality. For example, the image sensor 3303 may recordimages in the infrared wavelengths to provide additional diagnosticinformation to the memory 3302 and/or the processor 3301 (e.g., fordetection of skin conditions such as lipodystrophy presenting asswelling or hardness but not necessary skin color changes that may bedetected by a conventional camera). By providing additionalfunctionality to the image sensor 3303, more sophisticated and/oraccurate diagnoses may be made by the mobile device, and less userinteraction and/or judgment may be needed, according to the softwarefunctions performed by the mobile device.

The display 3304 preferably displays at least the view of the imagesensor 3303, along with additional information as discussed above and tobe discussed in further detail below. For example, the display 3304preferably displays the injection sites overlaid onto the image of thebody area viewed by the image sensor 3303, as well as feedbackinformation such as the guide arrow discussed above. The display 3304also preferably displays injection site status information for theinjection sites within view of the image sensor 3303. For example,injection sites that are lipodystrophic (hereinafter referred to as“lipos”) may be indicated as such to remind the user to avoid injectionsin those injection sites.

All of the components are preferably housed in a convenient housing3305, as is common in mobile devices. The mobile device furtherpreferably contains at least a touch screen user interface 3306 coupledto the display 3304 to provide a convenient user interface. The userinterface 3306 may of course include other elements known or foreseeablein mobile devices such as buttons, proximity sensors, gyroscopes,compasses, GPS sensors, photosensors, and the like. The mobile device3300 may further optionally include a pico-projector 3307, or the like,to work in conjunction with, or separate from the display 3304. Thepico-projector 3307, as discussed above, preferably projects informationdirectly onto the user's body to assist the user to achieve body areaand injection site diversity. Alternatively a virtual grid is placed onthe live image (or photograph) of the patient's body shown in thedisplay 3304.

The image sensor of embodiments of the present invention mayadvantageously be used for additional functions, such as scanning amedication box. Scanning a medication box may include, for example,scanning a QR code imprinted on the box. The app may require scanning ofa particular manufacturer's box to continue functioning or receivingupdates to the app, or scanning may trigger an advertisement or adviceto be displayed on the mobile device. In an advantageous businessscheme, and to encourage loyalty to a particular manufacturer, discountsmay be provided to users for continued use of the app, or for everypredetermined number of injections administered. The app can preferablyprovide additional feedback to the user, such as reminding him to changehis needles, or providing feedback on his compliance with his healthcareprovider's recommended therapy regimen.

The app can also be programmed to alert the user when the next injectionshould be administered based on the stored information mentioned above(e.g., injection regimen, injection data). The app can also beprogrammed to determine where the next injection site should be based onthe stored site rotation plan and past injection data (e.g., locationand time), and can include warnings to avoid identified and stored sitesexhibiting lipodystrophy (at least for a programmed duration of time oruntil site is cleared by a physician) or at least refrain fromsuggesting identified lipo sites (e.g., and optionally a selected numberof adjacent sites) for a next injection.

FIG. 34 further illustrates views that may be provided by a mobile phone3300 according to an illustrative embodiment of the invention. FIG. 34shows a screen view 410 on a display 3304 generated when a user selectsher abdomen as a body area. Injection locations on the abdomen indicatedgenerally at 412 are overlaid onto the smartphone display view 410 ofthe abdomen. The preferred current injection site (e.g., position “4”)is highlighted so that the user may locate the site using feedback fromthe mobile phone display view. In one embodiment, the user points herfinger to a location on the body area, the abdomen in FIG. 34, and thesoftware determines the location of the finger relative to the abdomen(e.g., using image information from the image sensor 3303 such as acamera), the location of the preferred current injection site on theabdomen (e.g., a designated location in accordance with an injectionregimen, or selected using criteria described above in connection withthe ISL device in FIG. 31 to track, monitor and manage injection siterotation) and provides an on-screen guide arrow pointing from theposition of the finger on the display to the position of the preferredcurrent injection site (e.g., position “4” as shown in FIG. 34). As theuser moves his finger, the guide arrow is updated until the finger iswithin a predetermined range of the preferred current injection site.Having determined the location of the current preferred injection siteusing feedback from the mobile phone, the user can inject in that site,and record the injection in the mobile phone. The mobile phone recordsthe injection and calculates the next preferred body area and injectionsite according to an injection regimen and site rotation plan programmedinto the mobile phone, and preferably coordinated with the user'shealthcare provider.

As will be appreciated, the software may be provided to a user's mobilephone by way of an app download as is customary in the art. The apppreferably tracks injection sites as they are administered, and inparticular stores the location of the last injection so that the usercan be alerted if they attempt to inject in the same spot twice in arow. The app preferably is programmed with an injection regimen, andadvises the user where the next injection should be administered. Theapp preferably permits a user to exclude certain body areas or injectionsites within a body area. The app may store a history of injection sitesand the time and date of injections, which history may also be sharedwith a healthcare provider.

As will be appreciated the mobile phone and camera combination mayperform additional functions. As shown in FIG. 35, the camera 3303analyzes coloration patterns of the user's body area, and determines ifany injection sites appear to be lipos. The mobile phone 3300 preferablyidentifies any such lipos 414 on a screen view 416 and alerts 418 theuser to perform further evaluation of the potential lipo by, forexample, palpating the area, if a lipo is determined to exist for one ormore injection sites by any combination of color change or manual entryof a site following palpation, the user can confirm the existence of thelipos (e.g., by an input on the touchscreen display 3304 or on anotheruser interface 3306 associated with the mobile phone), and the mobilephone advantageously records the lipo site locations (e.g., in memory3302) to update the ongoing injection regimen and/or site rotation planto avoid the lipo locations until sufficient time has been provided forthe lipos to heal. Lipo sites may be eliminated from the regimen by anycombination of determination by the patient or a healthcare providersuch as the user's doctor.

In another embodiment, the mobile phone according to an embodiment ofthe present invention is provided with a pico-projector 3307, or thelike. The pico-projector 3307 may be used in place of the mobile phonedisplay to project information onto the user's body. The informationpreferably includes site locations for the particular body area withinview of the mobile phone camera. The information may further includestatus information for the injection locations, and informationidentifying the current preferred injection site location. In thismanner, with information projected directly onto the user's body, theuser may more easily determine the correct current injection sitelocation.

In yet another embodiment, the mobile phone need not necessarily utilizethe camera 3303, but rather may simply record injection locationsaccording to user input. In this embodiment, the mobile phone preferablyis programmed to track the user's shot regimen as provided by hishealthcare provider, and alerts the user to injection times, andpreferred current injection body area and injection site in accordancewith a stored site rotation plan. As discussed above, the mobile phonemay further track injection sites to be avoided such as due to lipos, orthe like, and preferably alters the injection regimen according to anysuch conditions. With reference to FIG. 38, the phone app can generate ascreen 422 requesting user input on the selected body area where theuser wishes to inject. The phone app can be configured to display ascreen view 424 providing a designated distribution pattern for theinputted body area (e.g., a spiral pattern for the buttocks area, or agrid or circular pattern for the thigh or abdomen, or a grid for the armor for a abdomen section or quadrant, and so on) and, based on storeddata relating to history of injections for that body area and in whichsites, the phone can indicate a selected one of the target sites.Depending on the sophistication of the features provided by the phoneapp, the phone can simply indicate a pattern, or indicate a pattern, anda suggest target site in that pattern, or use the optical technologydescribed above to project a grid or use an optical mouse feature toassist the user in locating the target site on the body.

In a further embodiment of the present invention, the mobile phone 3300may be programmed to work in connection with particular medicationpackaging as discussed above in connection with FIGS. 25-28. That is,medication packaging may contain codes, such as QR codes, or the like,which may be scanned by the image sensor 3303 of the mobile device toidentify the medication packaging and/or injection regimen directed bythe medication packaging as shown in FIG. 37. In this embodiment, themobile device software preferably coordinates with the printed indiciaon the medication packaging. For example, in the case of four indiciaicons to indicate which body area for injection, the mobile device maypresent the same indicia icons (e.g. icons 230) as user interfaceelements for ease of recording injections as indicated by the examplescreen view 420. That is, for example, if the packaging indicia with an“X” indicated the abdomen as a body area for the next injection, thenthe mobile device would present the four indicia types (“X”, “O”,“Square”, “triangle”) as user interface elements, and the user simplypresses the “X” on the touchscreen 3304 to indicate that the “X”medication was injected in the abdomen. The mobile device softwarerecords an injection in the abdomen at the given time. In other words,the user presses a colored and/or shaped button on the mobile phonedisplay that corresponds to compartment of packaging from which the userremoved an insulin product for administration as illustrated in FIGS.25-28. The mobile app is programmed to provide daily and historical(e.g., over multiple days) tracking of injection site locations and suchinformation can be displayed in a simple, easy to understand manner,using the packaging printed indicia.

An illustrative method of using a mobile phone 3300 to assist a user indetermining a current injection site location according to anillustrative embodiment of the invention will now be described inconnection with FIG. 36. At step 3602, the device determines if the userhas activated the image sensor. If the user has not yet activated theimage sensor, then the method continues until the user does activate theimage sensor. If the user has activated the image sensor, then themethod continues at step 3603. At step 3603, the method determines ifthe user's body areas are already recorded in memory. If the body areasare not recorded in memory, then the method continues at step 3604. Instep 3604, body area registration is begun. At step 3605, the userselects the body area that they want to register. At step 3606, thedevice obtains and stores an image of the body area for latercomparison. At step 3607, the image of body area received by the bodysensor is stored in memory 3302 and analyzed by the processor. Theprocessor 3301 preferably determines key orientation points for futurereference against subsequent images obtained by the image sensor 3303 ofsame body area. At step 3608, the method determines if another body areaneeds to be registered. If another body area needs to registered, themethod returns to step 3604. If no further body areas need to beregistered then the method returns to the start 3601.

On the other hand, if at step 3603 the body areas are already stored inmemory, then the method continues at step 3609. At step 3609, the imagesensor 3303 is activated and the user preferably aims the image sensorat the body area they wish to inject into. Alternatively, the device cananalyze the user's injection shot regimen and determines which body areashould be utilized and advises the user to point the image sensor atthat body area. Once the image sensor 3303 obtains an image of thedesired body area, the image is compared with the registered body imagesat step 3610. At step 3611, the processor 3301 compares newly obtainedbody area images to the body areas images previously registered anddetermines if the body area currently being viewed is recognized. If thebody area is not recognized then the method returns to step 3610. If thebody area is recognized then the method continues at step 3612.

At step 3612, the processor 3301 determines the body area imageorientation. At step 3613, an image overlay is generated. The imageoverlay preferably shows injection sites and in particular highlightsthe current injection site. At step 3614, the device displays the imageoverlay with the image sensor view so that the user can see theinjection sites together with the body area and, in particular, the usercan see which of the injection sites is the current injection site. Theuser can then point her finger or any other suitable device or object ather own body area in order to pin point the current injection site. Thedevice, according to an illustrative embodiment of the invention,continues to analyze views of the body area obtained by the image sensorand to process those images.

At step 3615, the processor 3301 determines if a user pointer isrecognized in the image sensor data. If a user pointer is not recognizedthen the method returns to step 3610. If a user pointer is recognized,then the processor determines if the user pointer is near the currentinjection site at step 3616. If the processor determines that user ispointing at the current injection site then the method continues at step3617. At step 3617, the image overlay is updated to highlight that theuser pointer is pointing to the current injection site to indicate tothe user that they have located the current injection site and mayadminister the current injection at that injection site. If theprocessor 3301 recognizes the user pointer in the image data butdetermines that the user is not pointing to the current injection sitelocation, then processor determines the direction and distance betweenthe user pointer and the current site location at step 3618. At step3619, the image overlay is updated to include an arrow which points fromthe user pointer to the current site location in order to providefeedback to the user of which way she should move her user pointerobject (i.e., her finger) in order to locate the current injection site.The method continues in this manner at step 3620 until the user providesherself with an injection, at which point they may record the injectionin the device. Feedback can also be generated as audible tones thatchange frequency, volume, tone or provide pre-recorded verbal feedbackas the user approaches and becomes more distant from the targetinjection site.

Lipohypertrophy Education Tools

With reference to FIGS. 39A and 39B, a tactile education tool 430 isprovided that comprises a substrate or base and is formed at least onone side thereof with a material or combination of materials (e.g., atype of foam, rubber, plastic or other suitable synthetic material)having different sizes of mounds 432, 434 that are dimensioned andtextured to simulate lipos occurring in a patient's tissue. FIG. 39B isa cross-section of a section of FIG. 39A showing at least two differentsizes of mounds or simulated lipos 432 and 434 disposed in a tissuelayer (e.g., subcutaneous fat) 440 under a skin layer. It is to beunderstood that different synthetic materials can be used to simulatethe tactile characteristics of the skin layer 438 and the tissue layer(e.g., subcutaneous fat) 440, and that the simulated lipos can becreated using multiple layers or a unitary layer of material havingareas of different texture or density. Thus, a user can palpate the tool430 to develop a reference sensation for what a lipo typically feelslike such that the user is better able to palpate his own injectionareas or those of a patient to discern if a lipo is developing in thatbody area from insufficient injection site rotation.

The tool 430 can be provided on a substrate 436 sized to be included ina package as illustrated in FIGS. 25-28 or other packaging used fordifferent injection supplies besides disposable supplies such as a peninjector package. The tool 430 can be sized to have a credit card shapefor ease of portability and use by a patient or care giver, or providedwith a magnetic on the back of the substrate for hanging on a metallicsurface. Alternatively, the tool 430 can be dimensioned to be as largeas and therefore to simulate a body area on a typical patient. Forexample, the tool 430 can be configured as a three-dimensional model ofa body area subject to injection, or as a mannequin (e.g., full body,torso or other partial dummy or lay figure form) having the tool 430integrated into or otherwise affixed to conform to a target body area onthe mannequin for injections (e.g., an area on one or both of the thighs34, arms 38, or buttocks 36 or an area around the umbilicus 42 of theabdomen 32 of the mannequin). The size of the target body area and/ordistribution of lipos within that area can be selected and varied amongtarget body areas or among mannequins or modules configured to representdifferent patient types (e.g., patient types classified according to oneor more of size, age, sex, severity of lipo progression, injectionregimen, and so on) to reasonably simulate on the mannequin the locationof lipos that typically occur in the designated body for most liposufferers or for lip sufferers of a designated patient type.

With reference to FIGS. 40A through 40F, another education tool 450 isprovided that comprises print media (e.g., on a display screen 3304 oron paper, packaging or other printable material) indicating actions 452necessary for preventing or at least reducing lipohypertrophy incidentssuch as Detect 454, Rotate 456, Change 458 and Control 460. For example,the tool 450 can provide information on how to detect any occurrences oflipos 454, as well as a reminder to change needles 458, as shown in FIG.40A.

Also, one or more guidelines for rotating can 456 be provided asindicated in FIGS. 40B, 40C and 40D. For example, FIG. 40C illustrates agrid pattern 462 comprising a matrix of target injection sites 466 andarrows 464 for guiding a patient or user to inject at target sites in adesignated order and spatial pattern. Another example pattern forinjecting using site rotation is provided in FIG. 40D and comprises aspiral pattern 468, that is, a plurality of target injection sites 472distributed along a curved line with arrows 470 indicating an order forinjecting among the target injection locations 472.

FIG. 40E provides guidelines 460 for controlling blood sugar and insulinor other blood characteristics and/or for injecting medicine when liposare detected. FIG. 40F provides additional information onlipohypertrophy. The education tool 450 can, for example, employrecommendations for reducing lipohypertrophy from the Forum forInjection Technique (FIT) and available at www.fit4diabetes.com. Theprint media provided in FIGS. 40A through 40F can be provided togetherin a brochure or as a poster or other type of wall or other surfacedisplay, or on packaging. Alternatively, portions of the print media canbe provided on a brochure or in a poster or other type of wall or othersurface display, or on packaging.

FIG. 41 illustrates a standing display or wall display 442 having atactile lipo education tool 430 integrated in or affixed to a surfacethereof. The standing display can be, for example, affixed to a floor orotherwise balanced via a base or stand to allow a person to viewinformation 450 on at least one side thereof. For example, the display442 can be dimensioned to be between 4 and 7 feet in height and between2 and 4 feet wide. A tool 430 can be dimensioned, for example, to extendacross a selected area of the display as shown in FIG. 41 to allow auser to conveniently reach and touch the tool 30 and achieve a referencesensation from the simulated lipos 432 and 434 to facilitate detecting alipo in a patient's body. Alternatively, a plurality of tools 430 havingsmaller dimensions can be provided and distributed on the display 442 toallow multiple users to access respective tools 430 at the same time.Also, the density or texture and/or the distribution of the simulatedlipos 432 and 434 can be varied among a tool or tools 430 on a displayto demonstrate different sizes or patterns of lipos that may typicallyoccur given a particular body area and/or patient profile and/orinjection regimen or habitual injection pattern. The information 450 cancomprise, for example, a definition for “lipo” or “lipohypertrophy”(e.g., Lipohypertrophy is a thickened ‘rubbery’ lesion that appears inthe subcutaneous fat (SC) tissue of injecting sites in many patients whoinject insulin. In some patients, the lesions can be hard or scarlike.). Statistics regarding the impact of lipos or lipohypertrophy canalso be provided by the information 450 on the display 442 (e.g., 49% ofpatients with lipohypertrophy have glycemic variability; 39% of patientswith lipohypertrophy have unexplained hypoglycemia.)

FIG. 42 illustrates a lipo tactile education tool 430 disposed in aportable display case 444 having a lid 446 to enclose the tool 430 andany related surfaces or components providing information 450. As statedabove, the tool 430 is configured from synthetic material(s), forexample, to simulate lipos 432 and 434 (e.g., a texture or densitysimilar to that of a typical lipo) when palpated or otherwise touched bya user. The tool 430 can be affixed within the case 444 or detachablyplaced inside the case 444 for removal from the case 444 by a user formore convenient access to the tool for palpation. The information 450can comprise, for example, recommendations 452 for site rotation asillustrated in FIGS. 39A-39B and/or 40A-40F.

Additional Embodiments and Implementations

Although illustrative embodiments of the present invention have beendescribed with respect to minimizing the occurrence of, and in someembodiments detecting, lipohypertrophy, they can also be used for othertypes of lipodystrophy such as lipoatrophy which presents as areas wheresubcutaneous fat is wasting or degenerating and in which absorption ofinsulin may therefore be more rapid and unpredictable in comparison tonormal skin areas since insulin or medicament molecules may have ashorter distance to travel to reach a capillary.

Illustrative embodiments of the present invention have been describedwith reference to operations at a programmable device such as acomputerized insulin delivery or monitoring apparatus (e.g., pen needle,CGM, infusion pump), handheld device, mobile phone, or other userdevices. It is to be understood, however, that the present invention canalso be embodied as computer-readable codes on a computer-readablerecording medium. The computer-readable recording medium is any datastorage device that can store data which can thereafter be read by acomputer system. Examples of the computer-readable recording mediuminclude, but are not limited to, read-only memory (ROM), random-accessmemory (RAM), CD-ROMs, DVDs, magnetic tapes, floppy disks, optical datastorage devices. It is envisioned that aspects of the present inventioncan be embodied as carrier waves (such as data transmission through theInternet via wired or wireless transmission paths). Thecomputer-readable recording medium can also be distributed overnetwork-coupled computer systems so that the computer-readable code isstored and executed in a distributed fashion.

The components of the illustrative devices, systems and methods employedin accordance with the illustrated embodiments of the present inventioncan be implemented, at least in part, in digital electronic circuitry,analog electronic circuitry, or in computer hardware, firmware,software, or in combinations of them. These components can beimplemented, for example, as a computer program product such as acomputer program, program code or computer instructions tangiblyembodied in an information carrier, or in a machine-readable storagedevice, for execution by, or to control the operation of, dataprocessing apparatus such as a programmable processor, a computer, ormultiple computers. A computer program can be written in any form ofprogramming language, including compiled or interpreted languages, andit can be deployed in any form, including as a stand-alone program or asa module, component, subroutine, or other unit suitable for use in acomputing environment. A computer program can be deployed to be executedon one computer or on multiple computers at one site or distributedacross multiple sites and interconnected by a communication network.Also, functional programs, codes, and code segments for accomplishingthe present invention can be easily construed as within the scope of theinvention by programmers skilled in the art to which the presentinvention pertains. Method steps associated with the illustrativeembodiments of the present invention can be performed by one or moreprogrammable processors executing a computer program, code orinstructions to perform functions (e.g., by operating on input dataand/or generating an output). Method steps can also be performed by, andapparatus of the invention can be implemented as, special purpose logiccircuitry, e.g., an FPGA (field programmable gate array) or an ASIC(application-specific integrated circuit).

Processors suitable for the execution of a computer program include, byway of example, both general and special purpose microprocessors, andany one or more processors of any kind of digital computer. Generally, aprocessor will receive instructions and data from a read-only memory ora random access memory or both. The essential elements of a computer area processor for executing instructions and one or more memory devicesfor storing instructions and data. Generally, a computer will alsoinclude, or be operatively coupled to receive data from or transfer datato, or both, one or more mass storage devices for storing data, e.g.,magnetic, magneto-optical disks, or optical disks. Information carrierssuitable for embodying computer program instructions and data includeall forms of non-volatile memory, including by way of example,semiconductor memory devices, e.g., EPROM, EEPROM, and flash memorydevices; magnetic disks, e.g., internal hard disks or removable disks;magneto-optical disks; and CD-ROM and DVD-ROM disks. The processor andthe memory can be supplemented by, or incorporated in special purposelogic circuitry.

The above-presented description and figures are intended by way ofexample only and are not intended to limit the present invention in anyway except as set forth in the following claims. It is particularlynoted that persons skilled in the art can readily combine the varioustechnical aspects of the various elements of the various illustrativeembodiments that have been described above in numerous other ways, allof which are considered to be within the scope of the invention.

What is claimed is:
 1. An adhesive tape injection site indicatorremovably applied to a user's skin comprising: at least one ply, saidply having a plurality of holes, said plurality of holes are arranged insaid ply to correspond to a selected injection site distributionpattern; wherein the pattern is arranged such that, when an injection ismade into respective ones of the plurality of holes, the pattern causesthe respective injections to be spaced apart in the body area of theuser that is covered by the indicator.
 2. The adhesive tape injectionsite indicator of claim 1, wherein the pattern arranges the holes to bespaced apart a selected distance to minimize lipohypertrophy in the bodyarea when the respective injections are administered within a selectedperiod of time.
 3. The adhesive tape injection site indicator of claim2, wherein the pattern arranges the holes to be at least the selecteddistance of 0.3-2.0 centimeters from adjacent ones of the holes.
 4. Theadhesive tape injection site indicator of claim 1, further comprising aplurality of plies wherein corresponding holes in the plies aresubstantially aligned with respect to each other, and indicia areprovided with respect to a different one of the holes on respectiveplies to represent a target injection site on that ply.
 5. The adhesivetape injection site indicator of claim 1, further comprising a pluralityof plies, wherein the holes on each of the plies do not overlap.
 6. Anadhesive tape injection site indicator kit comprising: a plurality ofindicators configured to be removably applied to a user's skin; and atemplate configured to indicate a distribution pattern for theindicators when they are affixed to a body area of a patient to markrespective target injection sites.
 7. The adhesive tape injection siteindicator kit of claim 6, wherein the distribution pattern is configuredto space the target injection sites a selected distance from each otherto minimize lipohypertrophy in the body area when the respectiveinjections are administered within a selected period of time.
 8. Theadhesive tape injection site indicator of claim 7, wherein thedistribution pattern arranges the indicators to be at least the selecteddistance of 0.3-2.0 centimeters from adjacent ones of the indicators. 9.The adhesive tape injection site indicator kit of claim 6, wherein theindicators are stickers that each comprise adhesive to affix one sidethereof to the patient.
 10. The adhesive tape injection site indicatorkit of claim 6, wherein the template is configured to have theindicators affixed to one side thereof in the distribution pattern, andthe indicators are transferrable onto a patient's skin when the one sideof the template is placed against the patient.
 11. The adhesive tapeinjection site indicator kit of claim 10, wherein the indicators arestickers that each comprise double-sided adhesive to affix one sidethereof to the one side of the template and the other side thereof tothe patient.
 12. The adhesive tape injection site indicator kit of claim10, wherein the indicators each comprise transferrable ink on one sidethereof and are configured to transfer a marking onto the patient fromthe template to represent a target injection site.
 13. An imageprojection device configured to be handheld and to project an injectionsite target image onto a body area of a patient.
 14. The imageprojection device of claim 13, wherein the image is a patternrepresenting a plurality of target injection sites spaced apart relativeto each other to reduce lipohypertrophy.
 15. The image projection deviceof claim 14, wherein the target injection sites in the pattern arespaced apart from each other by a selected distance of 0.3-2.0centimeters.
 16. The image projection device of claim 13, wherein theimage projection device is deployed in a reusable part of an infusionpump set to facilitate selecting a location for deploying an injectionassembly associated with the infusion pump.
 17. The image projectiondevice of claim 13, further comprising: a memory device; a userinterface; a processing device connected to the image projection device,the memory device and the user interface, the memory device storing aplurality of injection site target images, the user interface beingconfigured to display a listing of the plurality of injection sitetarget images from which a user can select a target image, and theprocessing device being operable to control the image projection deviceto display a selected target image.
 18. The image projection device ofclaim 17, wherein the plurality of injection site target imagescomprises different target images for use on different body areas of thepatient.
 19. The image projection device of claim 18, wherein differenttarget images are different sizes and/or shapes depending on theircorresponding body areas.
 20. The image projection device of claim 18,wherein the plurality of injection site target images comprises at leastone target image that comprises different zones or sectors.